A study to evaluate the safety, pharmacokinetics, pharmacodynamics and therapeutic activity of RO7009789 (selicrelumab) in combination with vanucizumab or bevacizumab in patients with metastatic solid tumors
- Conditions
- Metastatic solid tumorCancer
- Registration Number
- ISRCTN35774409
- Lead Sponsor
- Genentech, Inc
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 94
Part I (dose escalation):
1. Histologically confirmed advanced/metastatic solid tumor (except prostate cancer and squamous non-small cell lung cancer [NSCLC])
Part II (expansion):
1. Histologically confirmed advanced/metastatic platinum-resistant ovarian carcinoma (aPROC), head and neck squamous cell carcinoma (HNSCC), or non-squamous NSCLC previously treated with anti-PD-L1/PD-1 inhibitor alone or in combination (e.g. atezolizumab, nivolumab, pembrolizumab, durvalumab, avelumab)
2. Checkpoint inhibitor (CPI)- experienced patients must have experienced documented disease progression on or after PD-L1/PD-1 inhibitor therapy
3. In CPI-experienced patients, the PD-L1/PD-1 inhibitor must have been part of the most recent systemic anticancer therapy administered prior to study enrollment
4. Eastern Cooperative Oncology Group (ECOG) performance status of 0, 1, or 2
5. Life expectancy =16 weeks
6. Adequate hematologic, renal, hepatic, and cardiovascular function
7. Measurable disease per Response Evaluation Criteria in Solid Tumors, v 1.1 (RECIST v1.1)
8. Tumors must be acceptable for biopsy. Participants in part II may be enrolled without a biopsy if the collection is not clinically feasible.
9. Agreement to use adequate contraceptive measures among men or among women of childbearing potential
Part I (dose escalation):
1. Prostate cancer or squamous NSCLC
2. Recent systemic anti-cancer treatment
3. Prior treatment with anti-programmed death (PD) 1 or anti-programmed death ligand (PD-L) 1 therapeutic antibody, vanucizumab, or compounds targeting cluster of differentiation (CD) 40 less than 4 weeks or 5xt1/2 (whichever is shorter) prior to enrollment
Part II (expansion):
1. Treatment targeting vascular endothelial growth factor (VEGF) or receptor within 12 months prior to enrollment
2. Systemic immunosuppressive medication within 2 weeks prior to day 1 of cycle 1
3. Chronic daily treatment with non-steroidal anti-inflammatory drugs
4. Unacceptable/unresolved toxicity from prior anti-cancer therapy
5. Patients who have had a surgical procedure or significant traumatic injury within 28 days prior to initiation of study treatment, or a core biopsy or other minor surgical procedure within 7 days prior to initiation of study treatment
6. Bisphosphonate therapy for symptomatic hypercalcemia
7. Significant vascular disease
8. History of hypertensive crisis or hypertensive encephalopathy
9. Current or recent use of aspirin (>325 mg/day) or clopidogrel (>75 mg/day)
10. History of vein thrombosis/thromboembolism, or use of anticoagulants within 7 days prior to study drug
11. Primary tumor in place in participants with colorectal cancer, or evidence of bowel involvement (metastasis, direct tumor invasion) in participants with other non-gastrointestinal cancer
12. Significant cardiovascular or cerebrovascular disease within 6 months prior to D1 of C1
13. History of fistula, bowel obstruction, perforation, or abscess
14. Prior radiotherapy to pelvis or abdomen, recto-sigmoid involvement, or bowel involvement among participants with aPROC
15. Severe non-healing wound, active ulcer, or untreated bone fracture
16. Pregnant or lactating women
17. History of autoimmune disease
18. Human immunodeficiency virus (HIV) or hepatitis B or C
19. Severe infection or receipt of a live/attenuated vaccine within 4 weeks prior to D1 of C1
20. Other significant malignancies within 3 years prior to D1 of C1
21. Allergy/hypersensitivity to study drug
22. Prior allogeneic bone marrow or solid organ transplant
23. Other conditions/findings that may contraindicate the use of study drug
24. Major surgery within 4 weeks prior to study drug
25. Known clinically significant liver disease
26. History of hemoptysis or bleeding diathesis, or known coagulopathies
27. Known symptomatic or untreated central nervous system (CNS) malignancy
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method