Clinical trial • Phase I/II • Oncology | Respiratory

(12M)-(1S,2S)-N-((63S,4S,Z)-11-ETHYL-12-(2-((S)-1-METHOXYETHYL)-5-(4-METHYLPIPERAZIN-1-YL)PYRIDIN-3-YL)-10,10-DIMETHYL-5,7-DIOXO-61,62,63,64,65,66-HEXAHYDRO-11H-8-OXA-2(4,2)-THIAZOLA-1(5,3)-INDOLA-6(1,3)-PYRIDAZINACYCLOUNDECAPHANE-4-YL)-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE for Non-small cell lung cancer | RAS G12D-mutated non-small cell lung cancer

Phase I/II trial of (12M)-(1S,2S)-N-((63S,4S,Z)-11-ETHYL-12-(2-((S)-1-METHOXYETHYL)-5-(4-METHYLPIPERAZIN-1-YL)PYRIDIN-3-YL)-10,10-DIMETHYL-5,7-DIOXO-61,62…

Overview

Trial Therapeutic Area
Oncology | Respiratory
Trial Disease
Non-small cell lung cancer | RAS G12D-mutated non-small cell lung cancer
Trial Stage
Phase I/II
Drug Modality
Small molecule | Monoclonal antibody

Key dates

Initial CTIS Submission Date
20-06-2025
First CTIS Authorization Date
06-10-2025

Trial design

open-label, no randomized comparator specified. treatment arms described include rmc-9805 with or without rmc-6236 combined with pembrolizumab, with or without chemotherapy (no arm doses/schedules specified in the json).-controlled, adaptive Phase I/II trial across 49 sites in Denmark, France, Netherlands and others.

Open Label
Yes
Comparator
No randomized comparator specified. Treatment arms described include RMC-9805 with or without RMC-6236 combined with pembrolizumab, with or without chemotherapy (no arm doses/schedules specified in the JSON).
Adaptive
True (study includes dose-finding elements: determination of RP2DS, safety lead-in cohorts and DLT assessment / dose-escalation elements such as safety lead-in for Cohort C3).
Biomarker Stratified
True, biomarker: RAS G12D mutation (enrolment restricted to patients with RAS-G12D-mutated NSCLC).
Single Multiple Or Escalation Dose Combined
Yes
Target Sample Size
86

Eligibility

Recruits 86 The trial record indicates vulnerable population selection (isVulnerablePopulationSelected = true). The JSON does not contain verbatim criteria describing consent/assent procedures for vulnerable participants; country-specific adult ICFs and related documents are listed but no explicit assent/consent handling text for vulnerable groups is provided in the JSON..

Vulnerable Population
The trial record indicates vulnerable population selection (isVulnerablePopulationSelected = true). The JSON does not contain verbatim criteria describing consent/assent procedures for vulnerable participants; country-specific adult ICFs and related documents are listed but no explicit assent/consent handling text for vulnerable groups is provided in the JSON.

Inclusion criteria

  • {"criterion_text":"- 1. Patients that are at least 18 years of age\n- 2. Patients that have NSCLC with RAS-G12D mutation.\n- 3. Patients that have had cancer treatment before or are not able to tolerate regular treatments.\n- 4. Patients that have at least 1 measurable tumor (lesion).\n- 5. Patients that have adequate organ function (bone marrow, liver, kidney) and blood clotting."}

Exclusion criteria

  • {"criterion_text":"- 1. Patients that have primary brain and spinal cord tumor.\n- 2. Patients that have gastrointestinal problems that may affect absorption of the study drug medicine\n- 3. Patients that had any major surgery in the last 4 weeks.\n- 4. Patients that have any other medical condition that may interfere with the study medicine.\n- 5. Patients that have previously taken targeted therapy for KRAS mutation."}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Incidence of DLTs; Part 1 and Part 2 (Cohort C3 safety lead-in only).","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 2. Incidence of TEAEs, TRAEs, SAEs, and clinically significant changes in vital signs, laboratory test values, and ECGs.","definition_or_measurement_approach":""}

Secondary endpoints

  • {"endpoint_text":"- 1. Concentrations of RMC-9805 and RMC-6236 (if applicable) in blood over time.","definition_or_measurement_approach":"Pharmacokinetic assessment: concentrations in blood over time (PK)."}
  • {"endpoint_text":"- 2. ORR and DOR as per RECIST v1.1","definition_or_measurement_approach":"Tumor response measured by RECIST v1.1 criteria (Objective Response Rate and Duration of Response)."}

Recruitment

Planned Sample Size
86
Recruitment Window Months
15
Consent Approach
Informed consent obtained from adult participants (age ≥18). Multiple country-specific subject information and informed consent forms are listed (languages and documents include Danish, French, Dutch, German, English, Spanish, Italian, Czech, Greek, etc.), plus pre-screening, pregnant partner and optional-biopsy ICFs. No explicit JSON text describing assent for minors (minors excluded by inclusion criteria).

Geography

Total Number Of Sites
49
Total Number Of Participants
130

Denmark

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
8
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Odense University Hospital
Department Name
Department of Oncology
Principal Investigator Name
Lise EckHoff
Principal Investigator Email
Line.Korfitz.Stenhoj@rsyd.dk
Contact Person Name
Lise EckHoff
Contact Person Email
Line.Korfitz.Stenhoj@rsyd.dk
Site Name
Rigshospitalet
Department Name
Department of Oncology
Principal Investigator Name
Kristoffer Staal Rohrberg
Principal Investigator Email
Kristoffer.Staal.Rohrberg@regionh.dk
Contact Person Name
Kristoffer Staal Rohrberg

France

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
13
Number Of Sites
14
Number Of Participants
38

Sites

Site Name
Assistance Publique Hopitaux De Paris
Department Name
Oncology Thoracic Unit Pneumology Service
Principal Investigator Name
Marie Wislez
Principal Investigator Email
marie.wislez@aphp.fr
Contact Person Name
Marie Wislez
Contact Person Email
marie.wislez@aphp.fr
Site Name
Centre Hospitalier Universitaire De Lille
Department Name
Pulmonology and thoracic Oncology Department
Principal Investigator Name
Alexis CORTOT
Principal Investigator Email
alexis.cortot@chu-lille.fr
Contact Person Name
Alexis CORTOT
Contact Person Email
alexis.cortot@chu-lille.fr
Site Name
Oncopole Claudius Regaud
Department Name
Medical Oncology Department
Principal Investigator Name
Audrey RABEAU
Principal Investigator Email
rabeau.audrey@iuct-oncopole.fr
Contact Person Name
Audrey RABEAU
Contact Person Email
rabeau.audrey@iuct-oncopole.fr
Site Name
Centre Hospitalier Universitaire De Nantes
Department Name
Oncology Medical Department
Principal Investigator Name
Elvire PONS-TOSTIVINT
Principal Investigator Email
elvire.pons@chu-nantes.fr
Contact Person Name
Elvire PONS-TOSTIVINT
Contact Person Email
elvire.pons@chu-nantes.fr
Site Name
Hopital Ambroise Pare
Department Name
Department of Respiratory Diseases and Thoracic-Oncology
Principal Investigator Name
Etienne Giroux-Leprieur
Principal Investigator Email
Etienne.giroux-leprieur@aphp.fr
Contact Person Name
Etienne Giroux-Leprieur
Site Name
Institut Curie
Department Name
Medical Oncology Department
Principal Investigator Name
Pauline DU RUSQUEC
Principal Investigator Email
pauline.durusquec@curie.fr
Contact Person Name
Pauline DU RUSQUEC
Contact Person Email
pauline.durusquec@curie.fr
Site Name
Assistance Publique Hopitaux De Paris
Department Name
Chest Department
Principal Investigator Name
Jacques Cadranel
Principal Investigator Email
Jacques.cadranel@aphp.fr
Contact Person Name
Jacques Cadranel
Contact Person Email
Jacques.cadranel@aphp.fr
Site Name
Institut Gustave Roussy
Department Name
DITEP (Medical Oncology in Early Drug Development Department)
Principal Investigator Name
Anas GAZZAH
Principal Investigator Email
anas.gazzah@gustaveroussy.fr
Contact Person Name
Anas GAZZAH
Contact Person Email
anas.gazzah@gustaveroussy.fr
Site Name
Hospices Civils De Lyon
Department Name
Pulmonology Department
Principal Investigator Name
Michael DURUISSEAUX
Principal Investigator Email
michael.duruisseaux@chu-lyon.fr
Contact Person Name
Michael DURUISSEAUX
Site Name
Centr Georges Francois Leclerc
Department Name
Medical Oncology Department
Principal Investigator Name
François GHIRINGHELLI
Principal Investigator Email
f.ghiringhelli@cgfl.fr
Contact Person Name
François GHIRINGHELLI
Contact Person Email
f.ghiringhelli@cgfl.fr
Site Name
Institut De Cancerologie De L Ouest
Department Name
Oncology Department
Principal Investigator Name
Frédéric Bigot
Principal Investigator Email
Frederic.bigot@ico.unicancer.fr
Contact Person Name
Frédéric Bigot
Site Name
Institut Bergonie
Department Name
Medical Oncology Department
Principal Investigator Name
Sophie COUSIN
Principal Investigator Email
s.cousin@bordeaux-unicancer.fr
Contact Person Name
Sophie COUSIN
Contact Person Email
s.cousin@bordeaux-unicancer.fr
Site Name
Hospital Foch
Department Name
Medical Oncology Department
Principal Investigator Name
Jaafar BENNOUNA
Principal Investigator Email
j.bennouna@hopital-foch.com
Contact Person Name
Jaafar BENNOUNA
Contact Person Email
j.bennouna@hopital-foch.com
Site Name
Centre Francois Baclesse
Department Name
Department of pneumology
Principal Investigator Name
Hubert CURCIO
Principal Investigator Email
h.curcio@baclesse.unicancer.fr
Contact Person Name
Hubert CURCIO
Contact Person Email
h.curcio@baclesse.unicancer.fr

Netherlands

Earliest CTIS Part Ii Submission Date
29-09-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
7
Number Of Sites
3
Number Of Participants
9

Sites

Site Name
Leids Universitair Medisch Centrum (LUMC)
Department Name
Department of Pulmonary Diseases
Principal Investigator Name
Egbert F. Smit
Principal Investigator Email
e.f.smit@lumc.nl
Contact Person Name
Egbert F. Smit
Contact Person Email
e.f.smit@lumc.nl
Site Name
Universitair Medisch Centrum Utrecht
Department Name
Medical Oncology
Principal Investigator Name
Hilde Nienhuis
Principal Investigator Email
oncostudies@umcutrecht.nl
Contact Person Name
Hilde Nienhuis
Contact Person Email
oncostudies@umcutrecht.nl
Site Name
Het Nederlands Kanker Instituut-Antoni van Leeuwenhoek Ziekenhuis Stichting
Department Name
Clinical Research Unit
Principal Investigator Name
Gerrina Ruiter
Principal Investigator Email
cpm-cru@nki.nl
Contact Person Name
Gerrina Ruiter
Contact Person Email
cpm-cru@nki.nl

Austria

Earliest CTIS Part Ii Submission Date
01-10-2025
Latest Decision Or Authorization Date
13-10-2025
Processing Time Days
12
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
Stadt Wien Wiener Gesundheitsverbund
Department Name
Abteilung für Innere Medizin und Lungenforschung
Principal Investigator Name
Maximilian Hochmair
Principal Investigator Email
maximilian.hochmair@gesundheitsverbund.at
Contact Person Name
Maximilian Hochmair
Site Name
Noe LGA Gesundheit Region Mitte GmbH
Department Name
Klinische Abteilung für Innere Medizin 1
Principal Investigator Name
Martin Wiesholzer
Principal Investigator Email
martin.wiesholzer@stpoelten.lknoe.at
Contact Person Name
Martin Wiesholzer

Germany

Earliest CTIS Part Ii Submission Date
24-09-2025
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
13
Number Of Sites
5
Number Of Participants
12

Sites

Site Name
University Hospital Cologne AöR
Department Name
Uniklinik Köln Klinik I für Innere Medizin
Principal Investigator Name
Jürgen Wolf
Principal Investigator Email
juergen.wolf@uk-koeln.de
Contact Person Name
Jürgen Wolf
Contact Person Email
juergen.wolf@uk-koeln.de
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Medizinische Klinik mit Schwerpunkt Onkologie, Hämatologie und Tumorimmunologie
Principal Investigator Name
Damian Rieke
Principal Investigator Email
damian.rieke@charite.de
Contact Person Name
Damian Rieke
Contact Person Email
damian.rieke@charite.de
Site Name
Technische Universitaet Dresden
Department Name
Medizinische Klinik und Poliklinik I
Principal Investigator Name
Martin Wermke
Principal Investigator Email
martin.wermke@uniklinikum-dresden.de
Contact Person Name
Martin Wermke
Site Name
Goethe University Frankfurt
Department Name
Medizinische Klinik II
Principal Investigator Name
Martin Sebastian
Principal Investigator Email
sebastian@med.uni-frankfurt.de
Contact Person Name
Martin Sebastian
Contact Person Email
sebastian@med.uni-frankfurt.de
Site Name
Thoraxklinik Heidelberg gGmbH
Principal Investigator Name
Farastuk Bozorgmehr
Principal Investigator Email
arastuk.bozorgmehr@med.uni-heidelberg.de
Contact Person Name
Farastuk Bozorgmehr

Czechia

Earliest CTIS Part Ii Submission Date
15-09-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
21
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Nemocnice AGEL Novy Jicin a.s.
Department Name
Oddeleni onkologie a radioterapie
Principal Investigator Name
Vojtěch Tlustý
Principal Investigator Email
Vojtech.tlusty@nnj.agel.cz
Contact Person Name
Vojtěch Tlustý
Contact Person Email
Vojtech.tlusty@nnj.agel.cz

Italy

Earliest CTIS Part Ii Submission Date
12-09-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
24
Number Of Sites
5
Number Of Participants
16

Sites

Site Name
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Department Name
Unità Operativa Complessa Fase 1
Principal Investigator Name
Gennaro Daniele
Principal Investigator Email
gennaro.daniele@policlinicogemelli.it
Contact Person Name
Gennaro Daniele
Site Name
Azienda Unita Sanitaria Locale Della Romagna
Department Name
Unità Clinica Fase 1 – UO Oncologia di Ravenna
Principal Investigator Name
Manolo D’Arcangelo
Principal Investigator Email
manolo.darcangelo@auslromagna.it
Contact Person Name
Manolo D’Arcangelo
Site Name
ASST Grande Ospedale Metropolitano Niguarda
Department Name
SC Oncologia Falck
Principal Investigator Name
Salvatore Siena
Principal Investigator Email
salvatore.siena@ospedaleniguarda.it
Contact Person Name
Salvatore Siena
Site Name
Azienda Ospedaliero-Universitaria San Luigi Gonzaga
Department Name
SSD Oncologia polmonare-A.O.U. San Luigi Gonzaga - Orbassano
Principal Investigator Name
Silvia Novello
Principal Investigator Email
silvia.novello@unito.it
Contact Person Name
Silvia Novello
Contact Person Email
silvia.novello@unito.it
Site Name
Istituto Europeo Di Oncologia S.r.l.
Department Name
Divisione di sviluppo di nuovi farmaci per terapie innovative
Principal Investigator Name
Giuseppe Curigliano
Principal Investigator Email
giuseppe.curigliano@ieo.it
Contact Person Name
Giuseppe Curigliano
Contact Person Email
giuseppe.curigliano@ieo.it

Spain

Earliest CTIS Part Ii Submission Date
17-09-2025
Latest Decision Or Authorization Date
07-10-2025
Processing Time Days
20
Number Of Sites
13
Number Of Participants
24

Sites

Site Name
Hospital Universitario Quironsalud Madrid
Department Name
NEXT Oncology Madrid Phase I Unit
Principal Investigator Name
Valentina Boni
Principal Investigator Email
vboni@nextoncology.eu
Contact Person Name
Valentina Boni
Contact Person Email
vboni@nextoncology.eu
Site Name
Hospital Clinico San Carlos
Department Name
Oncologia
Principal Investigator Name
Jorge Bartolome
Principal Investigator Email
Jorge.bartolome@salud.madrid.org
Contact Person Name
Jorge Bartolome
Site Name
Fundacion Instituto Valenciano De Oncologia
Department Name
Oncologia
Principal Investigator Name
David Lorente Estelles
Principal Investigator Email
dlorente@fivo.org
Contact Person Name
David Lorente Estelles
Contact Person Email
dlorente@fivo.org
Site Name
Hospital Universitari Vall D Hebron
Department Name
Oncologia
Principal Investigator Name
Patricia Iranzo
Principal Investigator Email
piranzo@vhio.net
Contact Person Name
Patricia Iranzo
Contact Person Email
piranzo@vhio.net
Site Name
Hospital Universitario Fundacion Jimenez Diaz
Department Name
Oncologia
Principal Investigator Name
Bernard Doger de Speville Uribe
Principal Investigator Email
bernard.doger@startmadrid.com
Contact Person Name
Bernard Doger de Speville Uribe
Contact Person Email
bernard.doger@startmadrid.com
Site Name
Hospital Universitario 12 De Octubre
Department Name
Oncologia
Principal Investigator Name
Luis Paz-Ares Rodriguez
Principal Investigator Email
luis.paz-ares@salud.madrid.org
Contact Person Name
Luis Paz-Ares Rodriguez
Contact Person Email
luis.paz-ares@salud.madrid.org
Site Name
University Hospital Virgen Del Rocio S.L.
Department Name
Oncologia
Principal Investigator Name
Alejandro Falcon
Principal Investigator Email
afalconglez@gmail.com
Contact Person Name
Alejandro Falcon
Contact Person Email
afalconglez@gmail.com
Site Name
Hospital Universitario Y Politecnico La Fe
Department Name
Oncologia
Principal Investigator Name
Oscar Juan Vidal
Principal Investigator Email
juan_osc@gva.es
Contact Person Name
Oscar Juan Vidal
Contact Person Email
juan_osc@gva.es
Site Name
Hospital Universitario Regional De Malaga
Department Name
Oncologia Medica
Principal Investigator Name
Vanesa Gutierrez
Principal Investigator Email
vgutierrezcald@gmail.com
Contact Person Name
Vanesa Gutierrez
Contact Person Email
vgutierrezcald@gmail.com
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Oncologia Medica
Principal Investigator Name
Maria Rosario Garcia Campelo
Principal Investigator Email
ma.rosario.garcia.campelo@sergas.es
Contact Person Name
Maria Rosario Garcia Campelo
Site Name
Clinica Universidad De Navarra
Department Name
Oncologia
Principal Investigator Name
Miguel Fernandez De Sanmamed
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Clinica Universidad De Navarra (Madrid)
Department Name
Oncologia
Principal Investigator Name
Miguel Fernandez De Sanmamed
Principal Investigator Email
msanmamed@unav.es
Contact Person Name
Miguel Fernandez De Sanmamed
Contact Person Email
msanmamed@unav.es
Site Name
Hospital Universitario Ramon Y Cajal
Department Name
Oncologia
Principal Investigator Name
Pilar Garrido
Principal Investigator Email
pgarrido@salud.madrid.org
Contact Person Name
Pilar Garrido
Contact Person Email
pgarrido@salud.madrid.org

Greece

Earliest CTIS Part Ii Submission Date
15-07-2025
Latest Decision Or Authorization Date
06-10-2025
Processing Time Days
83
Number Of Sites
4
Number Of Participants
16

Sites

Site Name
Henry Dunant Hospital Center
Department Name
D’ Oncology clinic & Clinical Trials Unit
Principal Investigator Name
Ioannis Mountzios
Principal Investigator Email
gmountzios@gmail.com
Contact Person Name
Ioannis Mountzios
Contact Person Email
gmountzios@gmail.com
Site Name
Thoracic General Hospital Of Athens I Sotiria
Department Name
Oncology Unit, 3'd Department of Ιnternal Medicine and Laboratory
Principal Investigator Name
Konstantinos Syrigos
Principal Investigator Email
ksyrigos.trials@gmail.com
Contact Person Name
Konstantinos Syrigos
Contact Person Email
ksyrigos.trials@gmail.com
Site Name
Geniko Nosokomeio Thessalonikis George Papanikolaou
Department Name
Pulmonary Department Aristotle University of Thessaloniki
Principal Investigator Name
Dionysios Spyratos
Principal Investigator Email
diospyrato@yahoo.gr
Contact Person Name
Dionysios Spyratos
Contact Person Email
diospyrato@yahoo.gr
Site Name
Athens Medical Center S.A.
Department Name
4th Department of Medical Oncology
Principal Investigator Name
Ippokratis Korantzis
Principal Investigator Email
ippokratis.korantzis@gmail.com
Contact Person Name
Ippokratis Korantzis
Contact Person Email
ippokratis.korantzis@gmail.com

Sponsor

Primary sponsor

Full Name
Revolution Medicines Inc.
Organisation Type
Pharmaceutical company
Country Of Registered Address
United States

Contract research organisations

Name
PPD Development LP
Responsibilities
Contract Research Organization, Clinical Database Management, Pharmacovigilance services.
Name
Icon Clinical Research LLC
Responsibilities
Collect and read ECG scans
Name
PPD Global Ltd.
Responsibilities
Collect and read ECG scans
Name
Propharma Group LLC

Third parties

  • {"country":"United States","full_name":"Perceptive Informatics Inc.","duties_or_roles":"Central Imaging","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"Electronic drug diaries","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Myonex LLC","duties_or_roles":"Clinical Supply","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Tempus AI Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"United States","full_name":"Edetek Inc.","duties_or_roles":"Stats Programing","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"PPD Global Ltd.","duties_or_roles":"Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Alturas Analytics Inc.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Propharma Group LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Aperio Clinical Outcomes LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Scout Clinical","duties_or_roles":"Patient travel & Reimbursement","organisation_type":"Hospital/Clinic/Other health care facility"}
  • {"country":"United States","full_name":"Sherpa Clinical Packaging LLC","duties_or_roles":"Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Guardant Health Inc.","duties_or_roles":"ctDNA Analysis","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United States","full_name":"Adaptive Biotechnologies Corp.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"PPD Denmark Filial Af PPD Scandinavia AB Sverige","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Icon Clinical Research LLC","duties_or_roles":"Collect and read ECG scans","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"Contract Research Organization, Clinical Database Management, Pharmacovigilance services.","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Discovery Life Sciences LLC","duties_or_roles":"","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Primevigilance Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Atreo Inc.","duties_or_roles":"","organisation_type":"Non-Pharmaceutical company"}

Investigational products

Investigational Product Name
DARAXONRASIB (RMC-6236)
Active Substance
(12M)-(1S,2S)-N-((63S,4S,Z)-11-ETHYL-12-(2-((S)-1-METHOXYETHYL)-5-(4-METHYLPIPERAZIN-1-YL)PYRIDIN-3-YL)-10,10-DIMETHYL-5,7-DIOXO-61,62,63,64,65,66-HEXAHYDRO-11H-8-OXA-2(4,2)-THIAZOLA-1(5,3)-INDOLA-6(1,3)-PYRIDAZINACYCLOUNDECAPHANE-4-YL)-2-METHYLCYCLOPROPANE-1-CARBOXAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
300 mg
Investigational Product Name
RMC-9805
Active Substance
(2S)-2-CYCLOPENTYL-2-[(5S)-2-[(2R,3R)-3-CYCLOPROPYL-1-METHYLAZIRIDINE-2-CARBONYL]-2,7-DIAZASPIRO[4.4]NONAN-7-YL]-N-[(6S,8S,14S)-21-[5-(4-CYCLOPROPYLPIPERAZIN-1-YL)-2-[(1S)-1-METHOXYETHYL]PYRIDIN-3-YL]-18,18-DIMETHYL-9,15-DIOXO-22-(2,2,2-TRIFLUOROETHYL)-5,16-DIOXA-2,10,22,28-TETRAZAPENTACYCLO[18.5.2.12,6.110,14.023,27]NONACOSA-1(26),20,23(27),24-TETRAEN-8-YL]ACETAMIDE
Modality
Small molecule
Routes Of Administration
ORAL
Route
ORAL
Maximum Dose
1200 mg
Investigational Product Name
PEMBROLIZUMAB
Active Substance
PEMBROLIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Maximum Dose
200 mg
Investigational Product Name
CARBOPLATIN
Active Substance
CARBOPLATIN
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Maximum Dose
750 mg
Investigational Product Name
PEMETREXED
Active Substance
PEMETREXED
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Maximum Dose
500 mg/m2
Investigational Product Name
CISPLATIN
Active Substance
CISPLATIN
Modality
Small molecule
Routes Of Administration
SOLUTION FOR INFUSION
Route
SOLUTION FOR INFUSION
Maximum Dose
75 mg/m2
Combination Treatment
Yes

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