Clinical trial · Interventional
Gevokizumab With Standard of Care Anti-cancer Therapies for Metastatic Colorectal, Gastroesophageal, and Renal Cancers
Phase Ib Study of Gevokizumab in Combination With Standard of Care Anti-cancer Therapies in Patients With Metastatic Colorectal Cancer, Gastroesophageal Cancer and Renal Cell Carcinoma
- 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 study will determine the pharmacodynamically-active dose of gevokizumab and the tolerable dose of gevokizumab in combination with the standard of care anti-cancer therapy in patients with metastatic colorectal cancer, metastatic gastroesophageal cancer and metastatic renal cell carcinoma, and the preliminary efficacy of gevokizumab in combination with the SOC anti-cancer therapy in subjects with mCRC and mGEC.
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
| Gastroesophageal Cancer | Colorectal Neoplasm | PROBABILISTIC | 0.70 |
| Renal Cell Carcinoma | Renal Cell Carcinoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cabozantinib | Drug | Cabozantinib | ALIAS |
| FOLFIRI | Drug | FOLFIRI Regimen | ALIAS |
| Gevokizumab | Drug | — | UNRESOLVED |
| Modified FOLFOX6 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Ramucirumab | Drug | Ramucirumab | ALIAS |
Design
Arms and outcomes
Arms (4)
- type
- EXPERIMENTAL
- label
- Cohort A: 1st line colorectal cancer
- description
- Treatment for 1st line metastatic colorectal cancer (mCRC) with Gevokizumab, modified FOLFOX6, bevacizumab
- interventionNames
- Drug: Gevokizumab
- Drug: Bevacizumab
- Drug: Modified FOLFOX6
- type
- EXPERIMENTAL
- label
- Cohort B: 2nd line colorectal cancer
- description
- Treatment for 2nd line mCRC with Gevokizumab, FOLFIRI, bevacizumab
- interventionNames
- Drug: Gevokizumab
- Drug: Bevacizumab
- Drug: FOLFIRI
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 100 Years
Show eligibility criteria text
Key Inclusion Criteria: For All Cohorts: * Adult ≥ 18 years old. * Metastatic disease not amenable to potentially curative surgery and with available archival tumor tissue or fresh tumor tissue biopsy. * Presence of at least 1 measurable lesion assessed by CT and/or MRI according to RECIST 1.1. * Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1. * Adequate bone marrow and organ function per defined criteria in the protocol. * Recovered from acute laboratory and clinical toxicities of prior anti cancer treatment to NCI CTCAE v5.0 grade ≤1 at time of screening, except alopecia and amenorrhea. For Cohort A: • First line metastatic colorectal adenocarcinoma. For Cohort B: • Second line metastatic colorectal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease and which must include a fluoropyrimidine and oxaliplatin. For Cohort C: • Second line metastatic gastroesophageal adenocarcinoma that has progressed on prior line of chemotherapy administered for metastatic disease, and which must include a platinum agent and fluoropyrimidine doublet. For Cohort D: • Second or third line metastatic renal cell carcinoma with a clear cell component and has received one or two lines of treatment for metastatic disease that included an anti angiogenic agent for at least 4 weeks with radiologic progression on that treatment. For subjects starting from Part 1a in Cohorts A and B: * Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment). * Not requiring immediate initiation of anti cancer therapy per investigator's best judgement. For subjects starting from Part 2 in Cohort C: • Serum hs CRP at screening ≥ 10 mg/L (per central laboratory assessment). Key Exclusion Criteria: For All Cohorts: * Currently receiving any of the prohibited medications or has contraindications as outlined in the 'Contraindications' to SOC regimen components. * Symptomatic brain metastases or brain metastases that require directed therapy (such as focal radiotherapy or surgery). * Suspected or proven immunocompromised state, or infections (as defined in the protocol). * Conditions that have a high risk of clinically significant bleeding after administration of anti VEGF agents. * Clinically significant, uncontrolled or recent (within last 6 months) cardiovascular disease. For Cohort D: * Concomitant medications, herbal supplements, and/or fruits and their juices that are known as strong inhibitors or inducers of CYP3A4/5, and medications that have a narrow therapeutic window and are predominantly metabolized through CYP3A4/5. * Impairment of GI function or GI disease that may significantly alter the absorption of cabozantinib. Other protocol-defined inclusion/exclusion criteria may apply
References
Publications (0)
Data not yet available