Colorectal NeoplasmsPhase 1NCT07859085
A Study to Evaluate the Safety and Activity of GDC-7035 With Anti-Cancer Therapies in Participants With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
A Phase 1 study testing GDC-7035, Panitumumab and mFOLFOX6 in people with Colorectal Neoplasms and Pancreatic Ductal Adenocarcinoma, run by Genentech, Inc..
Trial summary
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colorectal Neoplasms, Pancreatic Ductal Adenocarcinoma
- What is being tested?
- GDC-7035, Panitumumab and mFOLFOX6
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 388 participants
- Where
- No sites listed yet
- Study dates
- 31 Oct 2026to 30 Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
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
- Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
- 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 syndrome or other conditions that would interfere with enteral absorption
- Known and untreated, or active central nervous system (CNS) metastases
- Known clinically significant liver disease
- History of or active clinically significant cardiovascular dysfunction
- Other protocol-defined inclusion/exclusion criteria may apply.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: GO46205 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
About this study
Official title: A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.
- Being tested
- GDC-7035, Panitumumab, mFOLFOX6, FOLFIRI, mFOLFIRINOX
- Keywords
- KRAS G12D-mutation
- Medical subject headings
- Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GDC-7035Drug
Also called RO7782493
Participants will receive GDC-7035 as per the schedule specified in the protocol.
PanitumumabBiological
Participants will receive panitumumab in accordance with the local prescribing information.
mFOLFOX6Drug
Participants will receive mFOLFOX6 in accordance with the local prescribing information.
FOLFIRIDrug
Participants will receive FOLFIRI in accordance with the local prescribing information.
mFOLFIRINOXDrug
Participants will receive mFOLFIRINOX in accordance with the local prescribing information.
Gem-nabPDrug
Participants will receive Gem-nabP in accordance with the local prescribing information.
| Study group | Role | What they receive |
|---|---|---|
| Group A: GDC-7035 + mFOLFOX6 + Panitumumab | Experimental | Participants with CRC will receive GDC-7035 in combination with modified (levo)leucovorin, 5-fluorouracil (5-FU), oxaliplatin (mFOLFOX6) and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with mFOLFOX6 and panitumumab at doses determined to be safe in the safety run-in period. Receives: Drug: GDC-7035; Biological: Panitumumab; Drug: mFOLFOX6 |
| Group B: GDC-7035 + FOLFIRI + Panitumumab | Experimental | Participants with CRC will receive GDC-7035 in combination with leucovorin, 5-FU, irinotecan (FOLFIRI), and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with FOLFIRI and panitumumab at doses determined to be safe in the safety run-in period. Receives: Drug: GDC-7035; Biological: Panitumumab; Drug: FOLFIRI |
| Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy | Experimental | Participants with PDAC will receive GDC-7035 in combination with modified leucovorin, 5-FU, irinotecan, oxaliplatin (mFOLFIRINOX) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with mFOLFIRINOX at doses determined to be safe in the safety run-in period. Receives: Drug: GDC-7035; Drug: mFOLFIRINOX |
| Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy | Experimental | Participants with PDAC will receive GDC-7035 in combination with gemcitabine and nab-paclitaxel (Gem-nabP) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with Gem-nabP at doses determined to be safe in the safety run-in period. Receives: Drug: GDC-7035; Drug: Gem-nabP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Measured: Up to approximately 30 months
Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to Day 28
Secondary outcomes (3)
Objective Response Rate (ORR)
Measured: Up to approximately 30 months
Duration of Response (DOR)
Measured: Up to approximately 30 months
Progression-free Survival (PFS) After Randomization
Measured: Up to approximately 30 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2026
- Study start31 Oct 2026 (estimated)
- Primary completion30 Mar 2029 (estimated)
- Study completion30 Mar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Colorectal NeoplasmsStudies 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
- Randomised
- Intervention model
- Sequential
- Model description
- The study design includes both parallel and sequential interventional models.
- Masking
- None (open label)
- Enrolment
- 388 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
- NCT07859085
- Sponsor's protocol ID
- GO46205
- Other IDs
- 2026-525460-17-00
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase Ib, Multicenter, Randomized Study Evaluating the Safety and Activity of GDC-7035 With Anti-Cancer Therapies as First-Line Treatment in Patients With KRAS G12D-Mutated Unresectable Advanced or Metastatic Colorectal Cancer or Pancreatic Ductal Adenocarcinoma
- ClinicalTrials.gov ID
- NCT07859085
- Acronym / sponsor ID
- GO46205
- Keywords
- KRAS G12D-mutation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 388 participants (estimated)
- Lead sponsor
- Genentech, Inc.Industry (pharma, biotech, devices)
- Study start
- 31 Oct 2026 (estimated)
- Primary completion
- 30 Mar 2029 (estimated)
- Study completion
- 30 Mar 2029 (estimated)
- First posted
- 5 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary purpose of this study is to evaluate the safety of GDC-7035 as a single agent and in combination with other anti-cancer therapies in participants with KRAS G12D-mutated metastatic colorectal cancer (CRC) or pancreatic ductal adenocarcinoma (PDAC). The study consists of a safety run-in period followed by a randomized/expansion period.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- The study design includes both parallel and sequential interventional models.
| Arm | Type | Receives |
|---|---|---|
| Group A: GDC-7035 + mFOLFOX6 + Panitumumab | Experimental | Drug: GDC-7035, Biological: Panitumumab, Drug: mFOLFOX6Participants with CRC will receive GDC-7035 in combination with modified (levo)leucovorin, 5-fluorouracil (5-FU), oxaliplatin (mFOLFOX6) and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with mFOLFOX6 and panitumumab at doses determined to be safe in the safety run-in period. |
| Group B: GDC-7035 + FOLFIRI + Panitumumab | Experimental | Drug: GDC-7035, Biological: Panitumumab, Drug: FOLFIRIParticipants with CRC will receive GDC-7035 in combination with leucovorin, 5-FU, irinotecan (FOLFIRI), and panitumumab as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 in combination with FOLFIRI and panitumumab at doses determined to be safe in the safety run-in period. |
| Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy | Experimental | Drug: GDC-7035, Drug: mFOLFIRINOXParticipants with PDAC will receive GDC-7035 in combination with modified leucovorin, 5-FU, irinotecan, oxaliplatin (mFOLFIRINOX) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with mFOLFIRINOX at doses determined to be safe in the safety run-in period. |
| Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy | Experimental | Drug: GDC-7035, Drug: Gem-nabPParticipants with PDAC will receive GDC-7035 in combination with gemcitabine and nab-paclitaxel (Gem-nabP) as per the schedule specified in the protocol during the safety run-in period. Participants in the randomized or expansion period will also receive GDC-7035 as a single agent or in combination with Gem-nabP at doses determined to be safe in the safety run-in period. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Confirmed presence of the Kirsten rat sarcoma viral oncogene homolog (KRAS) G12D mutation as documented through central laboratory testing or prior local laboratory testing
- Agreement to adhere to the contraception requirements described in the protocol for participants of childbearing potential and participants who produce sperm
Key exclusion criteria (5 listed)
- Malabsorption syndrome or other conditions that would interfere with enteral absorption
- Known and untreated, or active central nervous system (CNS) metastases
- Known clinically significant liver disease
- History of or active clinically significant cardiovascular dysfunction
- Other protocol-defined inclusion/exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GDC-7035Also: RO7782493Participants will receive GDC-7035 as per the schedule specified in the protocol. | Drug | Group A: GDC-7035 + mFOLFOX6 + Panitumumab, Group B: GDC-7035 + FOLFIRI + Panitumumab, Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy, Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy |
| PanitumumabParticipants will receive panitumumab in accordance with the local prescribing information. | Biological | Group A: GDC-7035 + mFOLFOX6 + Panitumumab, Group B: GDC-7035 + FOLFIRI + Panitumumab |
| mFOLFOX6Participants will receive mFOLFOX6 in accordance with the local prescribing information. | Drug | Group A: GDC-7035 + mFOLFOX6 + Panitumumab |
| FOLFIRIParticipants will receive FOLFIRI in accordance with the local prescribing information. | Drug | Group B: GDC-7035 + FOLFIRI + Panitumumab |
| mFOLFIRINOXParticipants will receive mFOLFIRINOX in accordance with the local prescribing information. | Drug | Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy |
| Gem-nabPParticipants will receive Gem-nabP in accordance with the local prescribing information. | Drug | Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to approximately 30 months
Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to Day 28
3 secondary outcomes
Objective Response Rate (ORR)
Time frame: Up to approximately 30 months
Duration of Response (DOR)
Time frame: Up to approximately 30 months
Progression-free Survival (PFS) After Randomization
Time frame: Up to approximately 30 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Please use this form to submit your questions for a faster response: https://www.gene.com/contact-us/submit-medical-inquiry. Do not include or attach any medical records when emailing or completing the form. A nurse will respond within 24 business hours.Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Reference Study ID Number: GO46205 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
Clinical Trials study director
Hoffmann-La Roche
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GDC-7035, Panitumumab and mFOLFOX6 in people with Colorectal Neoplasms and Pancreatic Ductal Adenocarcinoma, run by Genentech, Inc..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Reference Study ID Number: GO46205 https://forpatients.roche.com/ No attachments to email below. (888-662-6728 (U.S. Only), global-roche-genentech-trials@gene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Adverse Events (AEs) (time frame: Up to approximately 30 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.