Solid TumorPhase 1NCT06619587
A Study to Evaluate Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination in Patients With Advanced Solid Tumors
A Phase 1 study testing Phase I Arm A and Phase I Arm B in people with Solid Tumor, run by Genentech, Inc. at 49 sites in 12 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Solid Tumor
- What is being tested?
- Phase I Arm A and Phase I Arm B
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 410 participants
- Where
- 49 sitesin 12 countries
- Study dates
- 14 Nov 2024to 31 May 2028
- Phase
- Phase 1
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Malabsorption or other condition that would interfere with enteral absorption
- Active brain metastases
- Clinically significant cardiovascular dysfunction or liver disease
Trial locations and contacts
49 sites in 12 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
49 sites in 12 countries
United States12 sites, 11 recruiting
- Recruiting
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
- Recruiting
University of Illinois
Chicago, Illinois, 60612
- Recruiting
Mary Crowley Medical Research Center
Dallas, Pennsylvania, 75230-2571
- Recruiting
Sarah Cannon Research Institute at HealthONE
Denver, Colorado, 80218
- Recruiting
START - Midwest - EDOS
Grand Rapids, Michigan, 49546-7062
- Recruiting
O'Quinn Medical Tower at McNair Campus
Houston, Texas, 77054
- Recruiting
UC San Diego Moores Cancer Center
La Jolla, California, 92093-1503
- Terminated
Florida Cancer Specialist-Lake Mary
Lake Mary, Florida, 32746
- Recruiting
SCRI Oncology Partners
Nashville, Tennessee, 37203
- Recruiting
Yale Cancer Center
New Haven, Connecticut, 06510
- Recruiting
Abramson Cancer Center;Univ of Pennsylvania
Philadelphia, Pennsylvania, 19104-5127
- Recruiting
Montefiore Einstein Cancer Center
The Bronx, New York, 10461
Spain6 sites, 6 recruiting
- Recruiting
Instituto de Investigacion Oncologica Vall dHebron (VHIO) - EPON
Barcelona, 08035
- Recruiting
Hospital Universitario 12 de Octubre
Madrid, 28041
- Recruiting
START Madrid_Hospital Universitario HM Sanchinarro_CIOCC
Madrid, 28050
- Recruiting
Hospital Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario Virgen del Rocio - PPDS
Seville, 41013
- Recruiting
Hospital Clinico Universitario de Valencia
Valencia, 46010
Israel4 sites, 4 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
- Recruiting
The Chaim Sheba Medical Center
Ramat Gan, 5262100
- Recruiting
Tel Aviv Sourasky Medical Center PPDS
Tel Aviv, 6423906
South Korea4 sites, 4 recruiting
- Recruiting
Seoul National University Bundang Hospital
Seongnam, 13620
- Recruiting
Asan Medical Center.
Seoul, 005505
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 3722
United Kingdom4 sites, 4 recruiting
- Recruiting
Western General Hospital;Edinburgh Cancer Center
Edinburgh, Midlothian, EH4 2LF
- Recruiting
NIHR UCLH Clinical Research Facility
London, W1T 7HA
- Recruiting
The Christie
Manchester, M20 4BX
- Recruiting
Royal Marsden Hospital - Surrey
Sutton, SM2 5PT
Australia3 sites, 3 recruiting
- Recruiting
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
- Recruiting
Slade Health Inward goods
Mount Kuring-Gai, New South Wales, 2080
- Recruiting
Peter Maccallum Cancer Centre
Parkville, Victoria, 3052
Canada3 sites, 3 recruiting
- Recruiting
Sir Mortimer B Davis Jewish General Hospital
Montreal, Quebec, H3T 1E2
- Recruiting
Princess Margaret Cancer Centre
Toronto, Ontario, M5G 1X6
- Recruiting
British Columbia Cancer Agency
Vancouver, British Columbia, V5Z 4E6
France3 sites, 3 recruiting
- Recruiting
Institut Bergonie
Bordeaux, 33076
- Recruiting
Centre Georges Francois Leclerc
Dijon, 21000
- Recruiting
Gustave Roussy
Villejuif, Val-de-Marne, 94805
Germany3 sites, 3 recruiting
- Recruiting
Universitätsklinikum Düsseldorf
Düsseldorf, North Rhine, 40225
- Recruiting
Universitätsmedizin Mannheim
Mannheim, 68167
- Recruiting
Universitätsklinikum Ulm
Ulm, Baden-Wurttemberg, 89081
Italy3 sites, 3 recruiting
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
- Recruiting
IRCCS Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
- Recruiting
Centro Richerche Cliniche di Verona
Verona, Veneto, 37134
Netherlands2 sites, 2 recruiting
- Recruiting
Universitair Medisch Centrum Groningen
Groningen, 9713 GZ
- Recruiting
Universitair Medisch Centrum Utrecht
Utrecht, 3584 CX
Singapore2 sites, 2 recruiting
- Recruiting
National University Hospital
Singapore, 119074
- Recruiting
National Cancer Centre
Singapore, 168583
About this study
Official title: A Phase I/II Dose-Escalation and Expansion Study Evaluating the Safety, Pharmacokinetics, and Activity of GDC-7035 as a Single Agent and in Combination With Other Anti-Cancer Therapies in Patients With Advanced Solid Tumors With a KRAS G12D Mutation
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.
- Conditions
- Solid Tumor
- Being tested
- Phase I Arm A, Phase I Arm B
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Phase I Arm ADrug
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035
Phase I Arm BDrug
Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies
| Study group | Role | What they receive |
|---|---|---|
| Phase I Arm A | Experimental | Dose escalation and expansion arm Receives: Drug: Phase I Arm A |
| Phase I Arm B | Experimental | Dose escalation and expansion arm Receives: Drug: Phase I Arm B |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants with Adverse Events, with Severity Determined According to the CTCAE v5.0 Grading Scale
Measured: 4 Years
Percentage of Participants with Dose Limiting Toxicity
Measured: 4 Years
Secondary outcomes (7)
Plasma Concentrations of GDC-7035 at Specified Timepoints
Measured: 4 Years
Blood Concentrations of GDC-7035 at Specified Timepoints
Measured: 4 Years
Plasma Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Measured: 4 Years
Blood Concentrations at Specified Timepoints of GDC-7035 Administered in the Fasted State or with a Standardized High-Fat Meal
Measured: 4 Years
Objective Response Rate Among Participants
Measured: 4 Years
Duration of Response Among Participants
Measured: 4 Years
Median Progression Free Survival Time Among Participants
Measured: 4 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Oct 2024
- Study start14 Nov 2024
- Primary completion31 May 2028 (estimated)
- Study completion31 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid TumorStudies of the same condition, open and under way.
- More trials run by Genentech, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 410 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Genentech, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06619587
- Sponsor's protocol ID
- GO45416
- Status last verified
- Oct 2026
- First submitted
- 27 Sep 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No