A Phase 1 interventional study of GDC-7035 and Panitumumab in Colorectal Neoplasms and Pancreatic Ductal Adenocarcinoma, sponsored by Genentech, Inc.. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-05.
Sponsored by Genentech, Inc. · Phase 1, Interventional, and Treatment
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.
5,599 studies on the registry are indexed under Colorectal Neoplasms; 1,459 are open to participants now.
This study's planned enrollment of 388 is above the median of 77 across 4,123 interventional studies indexed under Colorectal Neoplasms.
Browse Colorectal Neoplasms studies →Genentech, Inc. is the lead sponsor of 507 studies on the registry; 23 are open to participants now.
Of its 90 completed or terminated interventional studies of FDA-regulated products, 50 (56%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply.
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.
Drug: GDC-7035 · Biological: Panitumumab · Drug: mFOLFOX6
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.
Drug: GDC-7035 · Biological: Panitumumab · Drug: FOLFIRI
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.
Drug: GDC-7035 · Drug: mFOLFIRINOX
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.
Drug: GDC-7035 · Drug: Gem-nabP
Participants will receive GDC-7035 as per the schedule specified in the protocol.
Also known as: RO7782493
Participants will receive panitumumab in accordance with the local prescribing information.
Participants will receive mFOLFOX6 in accordance with the local prescribing information.
Participants will receive FOLFIRI in accordance with the local prescribing information.
Participants will receive mFOLFIRINOX in accordance with the local prescribing information.
Participants will receive Gem-nabP in accordance with the local prescribing information.
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
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
No study locations are listed for this record.
Plan to share: No
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Genentech, Inc.