Clinical trial · Interventional
A Study of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer (APM4187g)
A Phase Ib, Dose-Escalation Study of the Safety and Pharmacokinetics of PRO95780 in Combination With Cetuximab and Irinotecan Chemotherapy or the FOLFIRI Regimen With Bevacizumab in Patients With Previously Treated Metastatic Colorectal Cancer
- 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 a Phase Ib, open-label, multicenter, dose-escalation study designed to assess if PRO95780 in combination with two different irinotecan-containing regimens is safe and tolerable in patients with metastatic colorectal cancer (mCRC) who have progressed following, or cannot tolerate, first-line therapy with 5-fluorouracil-, oxaliplatin-, and bevacizumab-containing regimens. This study will also make a preliminary assessment of the anti-tumor activity of PRO95780 in combination with irinotecan and cetuximab or the FOLFIRI regimen plus bevacizumab.
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 |
|---|---|---|---|
| Colorectal Cancer | Malignant Colorectal Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| bevacizumab | Drug | Bevacizumab | ALIAS |
| cetuximab | Drug | Cetuximab | ALIAS |
| FOLFIRI regimen | Drug | FOLFIRI Regimen | ALIAS |
| irinotecan | Drug | Irinotecan | ALIAS |
| PRO95780 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- 1
- interventionNames
- Drug: cetuximab
- Drug: irinotecan
- Drug: PRO95780
- type
- EXPERIMENTAL
- label
- 2
- interventionNames
- Drug: bevacizumab
- Drug: FOLFIRI regimen
- Drug: PRO95780
Primary outcomes (1)
- measure
- Incidence and nature of dose-limiting toxicities
- timeFrame
- Through study completion or early study discontinuation
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Signed informed consent * Age ≥ 18 years * Histologically confirmed CRC with evidence of metastases and measurable tumor lesions * Documented disease progression following, or intolerance to, treatment with 5-fluorouracil, oxaliplatin, and bevacizumab-based therapy * Life expectancy \> 3 months * For patients of reproductive potential (males and females), use of reliable means for contraception (e.g., contraceptive pill, intrauterine device \[IUD\], physical barrier) throughout the trial and for 6 months following their final exposure to study treatment * Willingness and capability to be accessible for study follow-up Exclusion Criteria: * Patients who have a Kras mutation will be excluded from receiving cetuximab-containing regimens * Prior radiotherapy to a measurable metastatic lesion(s) to be used for response assessment, unless the lesion has progressed subsequent to the radiotherapy * Recent radiotherapy to a peripheral lesion, thoracic, abdominal, or pelvic field * Recent chemotherapy, hormonal therapy, or immunotherapy * Evidence of clinically detectable ascites * Other invasive malignancies within 5 years * History or evidence of active central nervous system (CNS) disease * Current or recent participation in another experimental drug study * Clinically significant cardiovascular disease * Active infection requiring parenteral antibiotics * Recent major surgical procedure, open biopsy, significant traumatic injury, fine needle aspirations, or anticipation of need for major surgical procedure during the course of the study * Known or suspected to be positive for the human immunodeficiency virus (HIV) * Known to be positive for hepatitis C or hepatitis B surface antigen * History of other disease, metabolic dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates use of an investigational drug or specified study treatment * Pregnancy (positive pregnancy test) or breast feeding * Serious, non-healing wound, ulcer, or bone fracture * Known sensitivity to any of the products administered during the study * Any disorder that compromises the ability of the patient to provide written informed consent and/or comply with study procedures
References
Publications (0)
Data not yet available