At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Phase I Arm A (drug), Phase I Arm B (drug)
- How long the study runs
- Study runs about 42 months (dates as stated)
- About the drug or intervention
- Phase I Arm A — drug: Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 · Phase I Arm B — drug: Dose escalation and expansion arm, with protocol-defined dose(s) of GDC-7035 in combination with other anti-cancer therapies
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 410
- Started
- 2024-11-14
- Last checked
- 2026-09
Plain English Summary
What is this study?
- • Testing a new treatment for solid tumor
- • Phase1 - 410 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with solid tumor
Where?
- • Edinburgh - Western General Hospital;Edinburgh Cancer Center
- • London - NIHR UCLH Clinical Research Facility
- • Manchester - The Christie
- • Sutton - Royal Marsden Hospital - Surrey
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Histologically documented advanced or that has spread solid tumor with KRAS G12D mutation
- ✓Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing...
Who cannot take part
- ✗Malabsorption or other condition that would interfere with enteral absorption
- ✗Active brain metastases
- ✗Clinically significant cardiovascular dysfunction or liver disease
See the full criteria
Where Is This Study? (4 UK sites)
Western General Hospital;Edinburgh Cancer Center
Edinburgh EH4 2LF, United Kingdom
NIHR UCLH Clinical Research Facility
London W1T 7HA, United Kingdom
The Christie
Manchester M20 4BX, United Kingdom
Royal Marsden Hospital - Surrey
Sutton SM2 5PT, United Kingdom
How to Get in Touch
Reference Study ID Number: GO45416 https://forpatients.roche.com/ No attachments to email below.
Sponsor contactCONTACT
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Sponsor contactCONTACT