Clinical trial · Interventional
GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
A Phase Ib, Open Label, Dose Escalation Study of the Safety and Pharmacology of GDC-0980 in Combination With a Fluoropyrimidine, Oxaliplatin, and Bevacizumab in Patients With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
This is an open-label, multicenter, Phase Ib, dose-escalation study designed to assess the safety, tolerability, and pharmacokinetics of oral GDC-0980 administered in combination with capecitabine and with mFOLFOX6 chemotherapy with bevacizumab added on at Cycle 5 in patients with advanced or metastatic solid tumors.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Solid Cancers | Malignant Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| capecitabine | Drug | Capecitabine | ALIAS |
| GDC-0980 | Drug | Apitolisib | ALIAS |
| mFOLFOX6 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- A
- interventionNames
- Drug: GDC-0980
- Drug: capecitabine
- type
- EXPERIMENTAL
- label
- B
- interventionNames
- Drug: GDC-0980
- Drug: bevacizumab
- Drug: mFOLFOX6
Primary outcomes (5)
- measure
- Incidence of adverse events
- timeFrame
- Up to 30 days after last dose of study treatment
- measure
- Incidence of dose limiting toxicities (DLTs)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented locally advanced or metastatic solid tumors for which established therapy is ineffective, not tolerable, or does not exist * Patients with histologically or cytologically documented locally advanced or metastatic breast cancer who have received at least one prior chemotherapy-based regimen for incurable disease (Arm A) * Patients with histologically or cytologically documented locally advanced or metastatic CRC who have not received prior oxaliplatin-based therapy within 1 year of initiation of study treatment. (Arm B) Exclusion Criteria: * Prior anti-cancer therapy that fulfills the following criteria: a total of more than six courses of an alkylating agent, a total of more than four courses of carboplatin-containing chemotherapy regimens, and a total of more than two courses of nitrosoureas or mitomycin C, high-dose chemotherapy requiring stem-cell support, and irradiation to \>= 25% of bone marrow-bearing areas * Current dyspnea at rest because of complications of advanced malignancy or other disease requiring continuous oxygen therapy * Known deficiency of dihydropyrimidine dehydrogenase (DPD) * Bisphosphonate therapy for symptomatic hypercalcemia * Known untreated or active central nervous system (CNS) metastases * Pregnancy, lactation, or breastfeeding For Arm B: * Inadequately controlled hypertension * Prior history of hypertensive crisis or hypertensive encephalopathy * History of myocardial infarction or unstable angina within 6 months prior to the first dose of study treatment * History of stroke or transient ischemic attacks within 6 months prior to the first dose of study treatment * Significant vascular disease within 6 months prior to the first dose of study treatment * History of hemoptysis within 1 month prior to the first dose of study treatment * Patients with one or more pulmonary tumor masses with evidence of cavitation * Evidence of bleeding diathesis or significant coagulopathy * Core biopsy or other minor surgical procedure, excluding placement of a vascular access device, within 7 days prior to the first dose of study treatment * History of abdominal fistula, GI perforation, or intra-abdominal abscess within 6 months prior to the first dose of study treatment * Clinical signs or symptoms of GI obstruction or requirement for parenteral hydration, parenteral nutrition, or tube feeding * Evidence of abdominal free air not explained by paracentesis or recent surgical procedure * Serious, non-healing wound, active ulcer, or untreated bone fracture * The presence of an ulcerating breast cancer tumor will not render a patient ineligible * Proteinuria
References
Publications (0)
Data not yet available