Clinical trial · Interventional
A Phase 1/2 Study to Evaluate MEDI4736
A Phase 1/2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of MEDI4736 in Subjects With Advanced Solid Tumors
NCT01693562CI-TRIAL-00051793completedPhase 1 / Phase 2Results postedClinicalTrials.gov clinicaltrialsProvenance
- 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, first-time-in-human study with a standard 3+3 dose-escalation phase in participants with advanced solid tumors followed by an expansion phase in participants with advanced solid tumors. An exploration cohort has been added to determine the safety using every 4 weeks (Q4W) dosing.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MEDI4736 | Drug | Durvalumab | ALIAS |
Design
Arms and outcomes
Arms (23)
- type
- EXPERIMENTAL
- label
- Escalation Cohort (MEDI4736 0.1 mg/kg Q2W)
- description
- Participants will receive intravenous (IV) infusion of MEDI4736 (durvalumab) 0.1 mg/kg every 2 weeks (Q2W) in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
- interventionNames
- Drug: MEDI4736
- type
- EXPERIMENTAL
- label
- Escalation Cohort (MEDI4736 0.3 mg/kg Q2W)
- description
- Participants will receive IV infusion of MEDI4736 0.3 mg/kg Q2W in the dose-escalation phase for maximum of 12 months or until confirmed progressive disease, initiation of alternative cancer therapy, unacceptable toxicity, withdrawal of consent, or development of other reason for treatment discontinuation, whichever occurs first.
- interventionNames
- Drug: MEDI4736
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Age 18 or older. * In the dose-escalation phase: histologically- or cytologically- confirmed advanced solid tumor that is refractory to standard therapy and for which no standard therapy exists. * In the dose-expansion phase: histologically- or cytologically- confirmed advanced solid tumor where if an approved first-line therapy is available, participants must have failed, be intolerant to, be ineligible for, or have refused * Eastern Cooperative Oncology Group (ECOG) status of 0 or 1. * Adequate organ and marrow function. * Participants must have at least 1 measurable lesion. * Available archived tumor tissue sample. * Willingness to provide consent for biopsy sample (dose-expansion only) Exclusion Criteria: * Any prior Grade ≥ 3 immune-mediated adverse event (imAE) while receiving immunotherapy * Prior exposure to any anti-PD-1 or anti-PD-L1 antibody * Any concurrent chemotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment. * Prior treatment with immunotherapy agents including, but not limited to, tumor necrosis factor receptor superfamily agonists or checkpoint inhibitors or natural killer (NK) cell inhibitors. * Active or prior documented autoimmune disease within the past 2 years * History of primary immunodeficiency * History of organ transplant that requires use of immunosuppressives * Symptomatic or untreated central nervous system (CNS) metastases requiring concurrent treatment * Other invasive malignancy within 2 years * Women who are pregnant or lactating * Uncontrolled intercurrent illness * Known history of tuberculosis * Known to be human immunodeficiency virus (HIV) positive * Known to be Hepatitis B or C positive (except HCC participants)
References
Publications (13)
- DERIVEDLi Q, Cristini V, Gupta A, Achour I, Barrett JC, Koay EJ. Clinical Validation of Mathematically Derived Early Tumor Dynamics for Solid Tumors in Response to Durvalumab. JCO Clin Cancer Inform. 2024 Jul;8:e2300254. doi: 10.1200/CCI.23.00254. PMID 38996196
- DERIVEDGavrilov S, Zhudenkov K, Helmlinger G, Dunyak J, Peskov K, Aksenov S. Longitudinal Tumor Size and Neutrophil-to-Lymphocyte Ratio Are Prognostic Biomarkers for Overall Survival in Patients With Advanced Non-Small Cell Lung Cancer Treated With Durvalumab. CPT Pharmacometrics Syst Pharmacol. 2021 Jan;10(1):67-74. doi: 10.1002/psp4.12578. Epub 2020 Dec 21. PMID 33319498
- DERIVEDSheth S, Gao C, Mueller N, Angra N, Gupta A, Germa C, Martinez P, Soria JC. Durvalumab activity in previously treated patients who stopped durvalumab without disease progression. J Immunother Cancer. 2020 Aug;8(2):e000650. doi: 10.1136/jitc-2020-000650. PMID 32847985
- DERIVEDZhang Q, Luo J, Wu S, Si H, Gao C, Xu W, Abdullah SE, Higgs BW, Dennis PA, van der Heijden MS, Segal NH, Chaft JE, Hembrough T, Barrett JC, Hellmann MD. Prognostic and Predictive Impact of Circulating Tumor DNA in Patients with Advanced Cancers Treated with Immune Checkpoint Blockade. Cancer Discov. 2020 Dec;10(12):1842-1853. doi: 10.1158/2159-8290.CD-20-0047. Epub 2020 Aug 14. PMID 32816849
- DERIVEDZajac M, Ye J, Mukhopadhyay P, Jin X, Ben Y, Antal J, Gupta AK, Rebelatto MC, Williams JA, Walker J. Optimal PD-L1-high cutoff for association with overall survival in patients with urothelial cancer treated with durvalumab monotherapy. PLoS One. 2020 Apr 27;15(4):e0231936. doi: 10.1371/journal.pone.0231936. eCollection 2020. PMID 32339189
- DERIVEDNordstrom BL, Oguz M, Chu BC, Ouwens M, Arkenau HT, Klein AB. Effectiveness of durvalumab versus chemotherapy in metastatic urothelial cancer: an observational, indirect comparison. J Comp Eff Res. 2020 Feb;9(3):191-199. doi: 10.2217/cer-2019-0163. Epub 2020 Jan 9.