Clinical trial · Interventional
A Study to Evaluate the Safety and Antitumor Activity in Subjects With Advanced Solid Tumors
Phase 1/1b, Open-Label, Dose-Escalation and Expansion Study to Evaluate the Safety and Antitumor Activity of MEDI3617 as a Single-Agent or in Combination Therapy in Adult Subjects With Advanced Solid Tumors
NCT01248949CI-TRIAL-00026685completedPhase 1Results 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)
To determine the maximum tolerated dose or optimal biological dose, and the safety profile of MEDI3617 when given as a single-agent or in combination with other chemotherapeutic agents in subjects with advanced solid malignancies resistant to standard therapy.
Conditions
Conditions (2)
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 Recurrent Ovarian Tumors | Ovarian Neoplasm | CURATED_BROADER | 0.78 |
| Advanced Solid Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Bevacizumab | Drug | Bevacizumab | ALIAS |
| Carboplatin | Drug | Carboplatin | ALIAS |
| MEDI3617 | Drug | — | UNRESOLVED |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (5)
- type
- EXPERIMENTAL
- label
- MEDI3617 SINGLE AGENT TOTAL
- description
- Participants will receive MEDI3617 via intravenous (IV) infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- interventionNames
- Drug: MEDI3617
- type
- EXPERIMENTAL
- label
- MEDI3617 + BEVACIZUMAB Q3W ESCALATION
- description
- Participants will receive MEDI3617 with bevacizumab via IV infusion every 3 weeks (Q3W) in each cycle until unacceptable toxicity, initiation of alternative anticancer treatment, documented disease progression, or other reasons. Each cycle consists of 21 days.
- interventionNames
- Drug: MEDI3617
- Drug: Bevacizumab
- type
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with confirmed diagnosis of advanced solid tumors (dose-escalation phase) or another solid tumor type based on antitumoral activity (dose-expansion phase) that are not responsive to standard therapy or for which no standard therapy exists * Patients must be 18 years of age or older * Karnofsky Performance Status ≥ 70 * Toxicities from previous cancer therapies must have recovered to CTCAE Grade = or \< 2 * Adequate organ and marrow function * Using adequate contraceptive measures, be surgically sterile or post-menopausal Exclusion Criteria: * Concurrently enrolled in another clinical study, except for non-interventiona observational studies, or if in a follow up period from a previous study * Receipt of any investigational anticancer therapy within 30 days prior to the first dose of MEDI3617, or in the case of monoclonal antibodies (eg, bevacizumab), 42 days prior to the first dose of MEDI3617 * Current or previous treatment with angiopoietin inhibitors, or inhibitors of Tie1 or Tie2 including, but not limited to, AMG386, CVX-060, XL880, and XL820 * Any concurrent chemotherapy, radiotherapy, immunotherapy, biologic or hormonal therapy for cancer treatment * Use of immunosuppressive medication or systemic steroids within 7 days prior to first dose of MEDI3617 * Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of subject safety or study results * Known bleeding diathesis * Pulmonary hemorrhage or gross hemoptysis within 6 months prior to enrollment * Therapeutic or palliative radiation therapy within 2 weeks prior to enrollment
References
Publications (0)
Data not yet available
No reference posted for this study.