Clinical trial · Interventional
A Study of Durvalumab (MEDI4736) and Monalizumab in Solid Tumors
A Phase 1/2 Study of Durvalumab and Monalizumab in Adult Subjects With Select 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 a multicenter, open-label, dose-escalation, dose-exploration and dose-expansion study to evaluate the safety, tolerability, antitumor activity, pharmacokinetic (PK), pharmacodynamics, and immunogenicity of durvalumab (MEDI4736) in combination with monalizumab (IPH2201) in adult participants with selected advanced solid tumors and the combination of durvalumab and monalizumab (IPH2201) standard of care systemic therapy with or without biological agent and monalizumab (IPH2201) with biological agent administered to participants with recurrent or metastatic colorectal cancer (CRC).
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 |
|---|---|---|---|
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Cetuximab | Drug | Cetuximab | ALIAS |
| Durvalumab | Drug | Durvalumab | ALIAS |
| mFOLFOX6 | Drug | — | UNRESOLVED |
| Monalizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (15)
- type
- EXPERIMENTAL
- label
- Dose-escalation Cohort 1: Monalizumab 22.5 mg Q2W + Durvalumab 1500 mg Q4W
- description
- Participants will receive intravenous (IV) infusions of durvalumab 1500 mg every 4 weeks (Q4W) in combination with monalizumab 22.5 mg every 2 weeks (Q2W) up to 3 years until unacceptable toxicity, documentation of confirmed disease progression (PD), or documentation of subject withdrawal for another reason.
- interventionNames
- Drug: Monalizumab
- Drug: Durvalumab
- type
- EXPERIMENTAL
- label
- Dose-escalation Cohort 2: Monalizumab 75 mg Q2W + Durvalumab 1500 mg Q4W
- description
- Participants will receive IV infusions of durvalumab 1500 mg Q4W in combination with monalizumab 75 mg Q2W up to 3 years until unacceptable toxicity, documentation of confirmed PD, or documentation of subject withdrawal for another reason.
- interventionNames
- Drug: Monalizumab
- Drug: Durvalumab
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: 1. Participants must have histologic documentation of advanced recurrent or metastatic cancer. 2. Participants must be at the recurrent/metastatic setting, with selected advanced solid tumors. 3. Participants must have at least one lesion that is measurable by RECIST v1.1 4. Part 3, Dose exploration, CRC participants can be treatment naïve but should not have received more than two line of systemic therapy in the recurrent/metastatic setting. Exclusion Criteria 1. Prior treatment with immunotherapy agents. Prior treatment with antitumor vaccines may be permitted upon discussion with the medical monitor. 2. Prior participation in clinical studies that include durvalumab alone or in combination, where the study has registrational intent and the analyses for the primary endpoint have not yet been completed 3. Receipt of any conventional or investigational anticancer therapy within 4 weeks prior to the first dose of study treatment 4. Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. Concurrent use of hormones for non-cancer-related conditions is acceptable.
References
Publications (2)
- DERIVEDPatel SP, Alonso-Gordoa T, Banerjee S, Wang D, Naidoo J, Standifer NE, Palmer DC, Cheng LY, Kourtesis P, Ascierto ML, Das M, Diamond JR, Hellmann MD, Carneiro BA. Phase 1/2 study of monalizumab plus durvalumab in patients with advanced solid tumors. J Immunother Cancer. 2024 Feb 2;12(2):e007340. doi: 10.1136/jitc-2023-007340. PMID 38309722
- DERIVEDHwang M, Fan C, Yue MS, Zhou D, Paturel C, Andre P, Cheng LY, Mitchell P, Kourtesis P, Ruscica D, Das M, Morsli N, Ren S, Gibbs M, Phipps A, Song X. Population Pharmacokinetics of Monalizumab in Patients With Advanced Solid Tumors. J Clin Pharmacol. 2023 Jul;63(7):817-829. doi: 10.1002/jcph.2220. Epub 2023 Apr 10. PMID 36852723