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Also known as Phase I Arm B, RO7782493
GDC-7035 · 2 trials · 3 indications
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| Phase I Arm A | EXPERIMENTAL | Dose escalation and expansion arm |
| Phase I Arm B | EXPERIMENTAL | Dose escalation and expansion arm |
| Name | Type | Description |
|---|---|---|
| GDC-7035 | DRUG | Participants will receive GDC-7035 as per the schedule specified in the protocol. |
| Panitumumab | BIOLOGICAL | Participants will receive panitumumab in accordance with the local prescribing information. |
| mFOLFOX6 | DRUG | Participants will receive mFOLFOX6 in accordance with the local prescribing information. |
| FOLFIRI | DRUG | Participants will receive FOLFIRI in accordance with the local prescribing information. |
| mFOLFIRINOX | DRUG | Participants will receive mFOLFIRINOX in accordance with the local prescribing information. |
| Gem-nabP | DRUG | Participants will receive Gem-nabP in accordance with the local prescribing information. |
| 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 |
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 ch...
GDC-7035 is an investigational small molecule oncology drug developed by Roche Holding AG. It is being studied in Phase 1 clinical trials in adults with KRAS G12D-mutated unresectable advanced or metastatic colorectal cancer, pancreatic ductal adenocarcinoma, and advanced solid tumors. It is a biomarker-selected therapy directed at tumors carrying the KRAS G12D mutation.
GDC-7035 is being evaluated in KRAS G12D-mutated unresectable advanced or metastatic colorectal cancer, both as a single agent and combined with anti-cancer therapies. It is investigational and has not been approved for any use. Trial NCT07859085 studies it in colorectal cancer and pancreatic ductal adenocarcinoma, and NCT06619587 studies it in advanced solid tumors.
GDC-7035 is developed by Roche Holding AG, which trades under the ticker RHHBY. Roche is running the Phase 1 program for the drug, including a study in KRAS G12D-mutated colorectal cancer and pancreatic ductal adenocarcinoma and a study in advanced solid tumors.
GDC-7035 is in Phase 1 clinical development. It is investigational and is being studied for safety, pharmacokinetics, and activity in adults with advanced solid tumors and in KRAS G12D-mutated colorectal cancer or pancreatic ductal adenocarcinoma. It has not been approved by the FDA for any indication.
GDC-7035 is in two Phase 1 trials. NCT06619587 is recruiting and evaluates the drug as a single agent and in combination in advanced solid tumors across the United States, Europe, Australia, Canada, Israel, Singapore, and South Korea. NCT07859085, not yet recruiting, studies GDC-7035 with anti-cancer therapies in KRAS G12D-mutated colorectal cancer and pancreatic ductal adenocarcinoma.
Yes. Phase I Arm A and Phase I Arm B are alternative names used for GDC-7035, which is the drug's primary designation. Readers searching under those arm labels are looking at the same Roche small molecule in Phase 1 development for KRAS G12D-mutated colorectal cancer, pancreatic ductal adenocarcinoma, and advanced solid tumors.