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 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.
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Estimated)
Phase
- Phase 1
Contacts and Locations
Study Contact
- Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Study Contact Backup
- Name: Reference Study ID Number: GO46205 https://forpatients.roche.com/ No attachments to email below.
- Phone Number: 888-662-6728 (U.S. Only)
- Email: global-roche-genentech-trials@gene.com
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group A: GDC-7035 + mFOLFOX6 + Panitumumab
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. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Other Names:
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive mFOLFOX6 in accordance with the local prescribing information. |
|
Experimental: Group B: GDC-7035 + FOLFIRI + Panitumumab
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. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Other Names:
Participants will receive panitumumab in accordance with the local prescribing information. Participants will receive FOLFIRI in accordance with the local prescribing information. |
|
Experimental: Group C: GDC-7035 + mFOLFIRINOX or GDC-7035 Monotherapy
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. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Other Names:
Participants will receive mFOLFIRINOX in accordance with the local prescribing information. |
|
Experimental: Group D: GDC-7035 + Gem-nabP or GDC-7035 Monotherapy
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. |
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Other Names:
Participants will receive Gem-nabP in accordance with the local prescribing information. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Number of Participants With Adverse Events (AEs)
Time Frame: Up to approximately 30 months
|
Up to approximately 30 months
|
|
Number of Participants With Key Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to Day 28
|
Up to Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Duration of Response (DOR)
Time Frame: Up to approximately 30 months
|
Up to approximately 30 months
|
|
Objective Response Rate (ORR)
Time Frame: Up to approximately 30 months
|
Up to approximately 30 months
|
|
Progression-free Survival (PFS) After Randomization
Time Frame: Up to approximately 30 months
|
Up to approximately 30 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Neoplasms by Site
- Neoplasms
- Intestinal Diseases
- Gastrointestinal Neoplasms
- Digestive System Neoplasms
- Digestive System Diseases
- Gastrointestinal Diseases
- Intestinal Neoplasms
- Rectal Diseases
- Colonic Diseases
- Colorectal Neoplasms
- Amino Acids, Peptides, and Proteins
- Proteins
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Panitumumab
- IFL protocol
Other Study ID Numbers
- GO46205
- 2026-525460-17-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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