Latest
Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact Astellas Expands Its 330 Million Euro Tralee Biopharma Facility with a Second Aseptic Filling Line to Double Drug-Product Capacity Xeolas Pharmaceuticals Opens 158,000 Sq Ft State-of-the-Art Baldoyle Facility to Scale Specialty Medicine Manufacturing Priya Life Science Partners with Fleming for the 9th Annual Corporate Compliance & Transparency in Life Sciences Summit in Zurich Ireland Has the Capital and the Lessons: Digital Project Management Is How They Become Delivery Dunbar Pharma Brings First Plant-Derived Dronabinol API to UK Market Through IPS Pharma Leveraging Priya Life Science as a Data Tracker: The Ultimate Use Case & Career Guide The €100K Reality Check: Why a Six-Figure Pharma Salary in Ireland Feels Different Than in Switzerland or Germany Ireland's €93.8 Billion Non-EU Pharma Export Engine: Trade Data, Destination Markets, and Economic Impact
Clinical Trials in Italy / 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 Italy 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)

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 Italy

A Study of Runimotamab in Participants With Locally Advanced or Metastatic HER2-Expressing Cancers 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
An Observational Study of the Progression of Intermediate Age-Related Macular Degeneration Active, not recruiting
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 Safety Extension Study of Trastuzumab Emtansine in Participants Previously Treated With Trastuzumab Emtansine Alone or in Combination With Other Anti-Cancer Therapy in One of the Parent Studies Active, not recruiting

Other trials for the same condition

An Extension Study for Patients Previously Enrolled in Studies With Pelabresib Recruiting
A Study on the Prevalence of Clinically Useful Mutations in Solid Tumor Characterized by Next Generation Sequencing Methods on Liquid Biopsy Analysis (POPCORN) Recruiting
A Study of 177Lu-FAP-2286 in Advanced Solid Tumors Recruiting
Study of Zanzalintinib in Combination With Immuno-Oncology or Other Agents in Participants With Solid Tumors Recruiting
FIH Trial of VERT-002 in Patients With Locally Advanced or Metastatic Solid Tumors With MET Alterations 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 Italy