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Clinical Trials in Spain / NCT06619587
Recruiting Phase 1

A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors

NCT06619587 · tracked via the Priya Life Science Spain tracker
Sponsor
Genentech, Inc
Phase
Phase 1
Started
2024-11-14
Last updated
2026-09-23

Condition(s) studied

Solid Tumor

Investigational drug(s) / intervention(s)

Phase I Arm APhase I Arm B

Phase I Arm A: Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035

Phase I Arm B: Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies

Study summary

This is a first-in-human Phase I/II, open-label, multicenter, dose-escalation and expansion study designed to evaluate the safety, pharmacokinetics, and preliminary activity of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with advanced or metastatic solid tumors that harbor the KRAS G12D mutation.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Histologically documented advanced or metastatic solid tumor with KRAS G12D mutation * Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm Exclusion criteria: * Malabsorption or other condition that would interfere with enteral absorption * Active brain metastases * Clinically significant cardiovascular dysfunction or liver disease

Primary outcome measure(s)

  • Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale — 4 Years
  • Percentage of Participants with Dose Limiting Toxicity — 4 Years

Trial sites (43)

FacilityCityRegionStatus
UC San Diego Moores Cancer Center La Jolla California Recruiting
Sarah Cannon Research Institute at HealthONE Denver Colorado Recruiting
Yale Cancer Center New Haven Connecticut Recruiting
Florida Cancer Specialist-Lake Mary Lake Mary Florida Completed
University of Illinois Chicago Illinois Recruiting
Dana Farber Cancer Institute Boston Massachusetts Recruiting
START - Midwest - EDOS Grand Rapids Michigan Recruiting
Montefiore Einstein Cancer Center The Bronx New York Recruiting
Mary Crowley Medical Research Center Dallas Pennsylvania Recruiting
Abramson Cancer Center;Univ of Pennsylvania Philadelphia Pennsylvania Recruiting
SCRI Oncology Partners Nashville Tennessee Recruiting
O'Quinn Medical Tower at McNair Campus Houston Texas Recruiting
St Vincent's Hospital Sydney Darlinghurst New South Wales Recruiting
Slade Health Inward goods Mount Kuring-Gai New South Wales Recruiting
Peter Maccallum Cancer Centre Parkville Victoria Recruiting
British Columbia Cancer Agency Vancouver British Columbia Recruiting
Princess Margaret Cancer Centre Toronto Ontario Recruiting
Sir Mortimer B Davis Jewish General Hospital Montreal Quebec Recruiting
Gustave Roussy Villejuif Val-de-Marne Recruiting
Institut Bergonie Bordeaux France Recruiting
Centre Georges Francois Leclerc Dijon France Recruiting
Rambam Health Care Campus Haifa Israel Recruiting
Hadassah University Hospital - Ein Kerem Jerusalem Israel Recruiting
The Chaim Sheba Medical Center Ramat Gan Israel Recruiting
Tel Aviv Sourasky Medical Center PPDS Tel Aviv Israel Recruiting
Centro Richerche Cliniche di Verona Verona Veneto Recruiting
Universitair Medisch Centrum Groningen Groningen Netherlands Recruiting
National University Hospital Singapore Singapore Recruiting
National Cancer Centre Singapore Singapore Recruiting
Seoul National University Bundang Hospital Seongnam South Korea Recruiting
Asan Medical Center. Seoul South Korea Recruiting
Seoul National University Hospital Seoul South Korea Recruiting
Severance Hospital, Yonsei University Health System Seoul South Korea Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON Barcelona Spain Recruiting
Hospital Universitario 12 de Octubre Madrid Spain Recruiting
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC Madrid Spain Recruiting
Hospital Universitario Virgen de la Victoria Málaga Spain Recruiting
Hospital Universitario Virgen del Rocio - PPDS Seville Spain Recruiting
Hospital Clinico Universitario de Valencia Valencia Spain Recruiting
Western General Hospital;Edinburgh Cancer Center Edinburgh Midlothian Recruiting

+ 3 more sites — see the full list on the official registry below.

More Genentech, Inc. trials in Spain

A Study Evaluating the Efficacy and Safety of Giredestrant Plus Everolimus Compared With the Physician's Choice of Endocrine Therapy Plus Everolimus in Participants With Estrogen Receptor-Positive, HER2-Negative, Locally Advanced or Metastatic Breast Cancer (evERA Breast Cancer) Active, not recruiting
A Study of GDC-9545 Alone or in Combination With Palbociclib and/or Luteinizing Hormone-Releasing Hormone (LHRH) Agonist in Locally Advanced or Metastatic Estrogen Receptor-Positive Breast Cancer Active, not recruiting
A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers Active, not recruiting
A Study of the Efficacy and Safety of Adjuvant Autogene Cevumeran Plus Atezolizumab and mFOLFIRINOX Versus mFOLFIRINOX Alone in Participants With Resected PDAC Active, not recruiting
A Study to Evaluate the Safety, Pharmacokinetics, and Activity of GDC-6036 Alone or in Combination in Participants With Advanced or Metastatic Solid Tumors With a KRAS G12C Mutation Active, not recruiting

Other trials for the same condition

Phase 1/2 Study to Evaluate TH9619 in the Treatment of Advanced Solid Tumors Recruiting
Phase I Trial to Determine the Dose and Evaluate the PK and Safety of Lutetium Lu 177 Edotreotide Therapy in Pediatric Participants With SSTR-positive Tumors Recruiting
A Study to Evaluate the Safety, Tolerability, and Efficacy of MORAb-202 (Herein Referred to as Farletuzumab Ecteribulin), a Folate Receptor Alpha (FRα)-Targeting Antibody-drug Conjugate (ADC) in Participants With Selected Tumor Types Recruiting
A Study to Find a Suitable Dose of ASP5834 in Adults With Solid Tumors Recruiting
Safety and Preliminary Anti-Tumor Activity of TYRA-300 in Advanced Urothelial Carcinoma and Other Solid Tumors With FGFR3 Gene Alterations Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06619587 on ClinicalTrials.gov ↗ ← All trials in Spain