GVV858 for Hormone receptor-positive, HER2-negative breast cancer | Advanced solid tumors

Inclusion criteria

• {"criterion_text":"- Age ≥ 18 years old.\n- Phase I, Dose escalation: Patients with one of the following histologically or cytologically confirmed advanced cancers, for whom no standard therapy is available or appropriate in the judgement of the investigator: HR+/HER2- advanced breast cancer (aBC) with disease progression on or following, or have been intolerant to, at least one line of hormone-based therapy in combination with a CDK4/6i for advanced disease (or during or within 12 months of completing adjuvant endocrine therapy (ET) plus CDK4/6i therapy), and at least one additional line of systemic therapy for metastatic disease. Locally advanced or metastatic solid malignancy with CCNE-1 amplification.\n- Phase I, Dose expansion: Patients with one of the following histologically or cytologically confirmed advanced cancers, for whom no standard therapy is available or appropriate in the judgement of the investigator: HR+/HER2- aBC with disease progression on or following, or have been intolerant to, at least one line of hormone-based therapy in combination with a CDK4/6i for advanced disease (or during or within 12 months of completing adjuvant ET plus CDK4/6i therapy), and at least one additional line of systemic therapy for metastatic disease. Advanced or metastatic ovarian cancer (OC) with CCNE-1 amplification, following progression on or after, or intolerance to, standard-of-care (SOC) therapy. Advanced or metastatic gastric or esophageal adenocarcinoma (GEA) with CCNE-1 amplification, following progression on or after, or intolerance to, SOC therapy. Metastatic castration-resistant prostate cancer (mCRPC) with disease progression on or after, or intolerance to, at least one line of androgen receptor pathway inhibitor therapy (ARPI) and at least one line of taxane-based chemotherapy, and no more than 3 total prior lines of systemic therapy for metastatic disease.\n- Phase II: HR+/HER2- a BC with disease progression on or after an endocrine therapy in combination with a CDK4/6 inhibitor for advanced disease, with no more than 2 total lines of endocrine therapy for advanced disease, and no prior cytotoxic chemotherapy or antibody-drug conjugate therapy for advanced disease.\n- Measurable disease as determined by RECIST v1.1, with the following exceptions: aBC only: If no measurable disease is present, then at least one predominantly lytic bone lesion must be present that can be accurately assessed at baseline and is suitable for repeated assessment. mCRPC only: If no measurable disease is present per PCWG3 modified RECIST, then at least one metastatic lesion must be present on bone scan imaging obtained prior to C1D1."}

Exclusion criteria

• {"criterion_text":"- Patients with inadequate bone marrow and/or organ function.\n- Presence of symptomatic central nervous system (CNS) metastases or CNS metastases that require local therapy or increasing doses of corticosteroids within 2 weeks prior to study entry.\n- Patients with symptomatic visceral disease, including visceral crisis.\n- For patients with breast cancer only: Patient is concurrently using hormone replacement therapy. Pre/perimenopausal women or men with breast cancer who are unwilling or unable to be treated with a Luteinizing Hormone-Releasing Hormone (LHRH) agonist (goserelin or leuprolide) for gonadal suppression, as per locally approved label (see Protocol Section 6.1.1).\n- Women of childbearing potential (WOCBP) who are unwilling to use highly effective contraception methods.\n- Pregnant or nursing women."}

Primary endpoints

• {"endpoint_text":"- Phase I: Safety: Incidence and severity of dose-limiting toxicities (DLTs), adverse events (AEs) and serious adverse events (SAEs), including changes in lab values, vital signs, electrocardiograms (ECGs). Tolerability: Frequency of dose interruptions, reductions, discontinuations, dose intensity.","definition_or_measurement_approach":"Safety: incidence and severity of DLTs, AEs and SAEs, including changes in laboratory values, vital signs and ECGs. Tolerability: frequency of dose interruptions, reductions, discontinuations and dose intensity (as described in protocol)."}
• {"endpoint_text":"- Phase II: Safety: Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), including changes in lab values, vital signs, electrocardiograms (ECGs). Tolerability: Frequency of dose interruptions, reductions, discontinuations, dose intensity.","definition_or_measurement_approach":"Safety: incidence and severity of AEs and SAEs including lab, vital signs and ECG changes. Tolerability: frequency of dose interruptions, reductions, discontinuations and dose intensity (as described in protocol)."}

Secondary endpoints

• {"endpoint_text":"- Phase II: ORR, BOR, DCR, CBR, PFS and duration of response (DOR) per investigator assessment of RECIST v1.1. Plasma concentrations of GVV858 and derived PK parameters (e.g., AUC, Tmax, and Cmax).","definition_or_measurement_approach":"Tumour response endpoints (ORR, BOR, DCR, CBR, PFS, DOR) assessed per investigator using RECIST v1.1. PK endpoints: plasma concentrations and derived PK parameters (AUC, Tmax, Cmax)."}
• {"endpoint_text":"- Phase I: Plasma concentrations of GVV858 and derived PK parameters (e.g., AUC, Tmax, Cmax). ORR, BOR, DCR, CBR, and PFS per investigator assessment of response evaluation criteria in solid tumors (RECIST v1.1), or local PCWG3 criteria including PCWG3-modified RECIST v1.1 (prostate cancer patients only).","definition_or_measurement_approach":"PK: plasma concentrations and derived parameters (AUC, Tmax, Cmax). Tumour response: ORR, BOR, DCR, CBR, PFS assessed by investigator per RECIST v1.1 or PCWG3-modified RECIST v1.1 for prostate cancer."}

France

Earliest CTIS Part Ii Submission Date

17-03-2026

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

31

Number Of Sites

1

Number Of Participants

8

Czechia

Earliest CTIS Part Ii Submission Date

14-04-2026

Latest Decision Or Authorization Date

16-04-2026

Processing Time Days

2

Number Of Sites

1

Number Of Participants

7

Denmark

Earliest CTIS Part Ii Submission Date

15-04-2026

Latest Decision Or Authorization Date

21-04-2026

Processing Time Days

6

Number Of Sites

1

Number Of Participants

7

Germany

Earliest CTIS Part Ii Submission Date

10-04-2026

Latest Decision Or Authorization Date

17-04-2026

Processing Time Days

7

Number Of Sites

2

Number Of Participants

11

Italy

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

22-04-2026

Processing Time Days

22

Number Of Sites

2

Number Of Participants

9

Spain

Earliest CTIS Part Ii Submission Date

31-03-2026

Latest Decision Or Authorization Date

20-04-2026

Processing Time Days

20

Number Of Sites

2

Number Of Participants

13

Primary sponsor

Full Name

Novartis Pharma AG

Organisation Type

Pharmaceutical company

Country Of Registered Address

Switzerland

Contract research organisations

Name

Syneos Health Inc.

Responsibilities

code:1

Name

Parexel International (IRL) Limited

Responsibilities

code:12

Name

Icon Clinical Research Limited

Responsibilities

codes:1,4

Name

IQVIA Limited

Responsibilities

codes:1,13

Name

Iqvia Inc.

Responsibilities

code:3

Name

Veeda Clinical Research Limited

Responsibilities

code:4

Third parties

• {"country":"United States","full_name":"EPL Pathology Archives LLC","duties_or_roles":"Biomarkers","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"code:1","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Foundation Medicine Inc.","duties_or_roles":"Biomarkers","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Parexel International (IRL) Limited","duties_or_roles":"code:12","organisation_type":"Pharmaceutical company"}
• {"country":"India","full_name":"Veeda Clinical Research Limited","duties_or_roles":"code:4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Navigate Biopharma Services Inc.","duties_or_roles":"Biomarkers","organisation_type":"Pharmaceutical company"}
• {"country":"France","full_name":"Creapharm Clinical Supplies","duties_or_roles":"code:14","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Medidata Solutions Inc.","duties_or_roles":"code:7","organisation_type":"Non-Pharmaceutical company"}
• {"country":"Belgium","full_name":"CellCarta","duties_or_roles":"Biomarkers","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United States","full_name":"Bioagilytix Labs LLC","duties_or_roles":"Biomarkers","organisation_type":"Pharmaceutical company"}
• {"country":"Ireland","full_name":"Icon Clinical Research Limited","duties_or_roles":"codes:1,4","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Somalogic Operating Co. Inc.","duties_or_roles":"Biomarkers","organisation_type":"Laboratory/Research/Testing facility"}
• {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"codes:1,13","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Iqvia Inc.","duties_or_roles":"code:3","organisation_type":"Pharmaceutical company"}