Clinical trial · Interventional
A Phase 1 Study of ADA-011 for Subjects With Advanced Solid Tumors
A Phase 1, Open-Label, Multicenter Study of ADA-011 as Monotherapy and in Combination With a Checkpoint Inhibitor for Subjects With Advanced Solid Tumors
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Internal company decision (non-safety related)
Summary
Brief summary (as posted)
This study consists of dose escalation evaluation to determine the safety and tolerability of ADA-011 as a monotherapy. Following dose escalation, one or more dose expansion cohorts in selected indications will be explored to further evaluate the safety, tolerability, and preliminary efficacy of ADA-011.
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 |
|---|---|---|---|
| Solid Tumor, Adult | Adult Solid Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ADA-011 | Drug | — | UNRESOLVED |
| PD(L)-1 inhibitor | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- ADA-011 Monotherapy Dose Escalation
- description
- ADA-011 monotherapy will be administered intravenously (IV), every 3 weeks (Q3W) at escalating doses starting with Cycle 1, Day 1, until participant withdrawal. Participants enroll with histologically or cytologically confirmed solid tumors.
- interventionNames
- Drug: ADA-011
- type
- EXPERIMENTAL
- label
- ADA-011 Monotherapy Dose Expansion
- description
- ADA-011 monotherapy with the preliminary recommended phase 2 dose (RP2D) of ADA-011, in participants with histologically or cytologically confirmed solid tumors.
- interventionNames
- Drug: ADA-011
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Histologically or cytologically documented, incurable or metastatic solid tumor that is advanced (nonresectable) or recurrent and progressing since the last antitumor therapy and for which no recognized standard therapy exists * Eastern Cooperative Oncology Group (ECOG) performance status ≤2 * Measurable disease per RECIST v1.1 or per other criteria best suited for the specific tumor type being evaluated * Adequate organ function Exclusion Criteria: * Treatment with any local or systemic antineoplastic therapy (including chemotherapy, hormonal therapy, or radiation) within 2 weeks prior to the first dose of ADA-011 * Chronic use of corticosteroids in excess of 10 mg daily of prednisone or equivalent within 4 weeks prior to the first dose of ADA-011 * Major trauma or major surgery within 4 weeks prior to the first dose of ADA-011 * AEs from prior anticancer therapy that have not resolved to Grade ≤1 except for alopecia * Known, central nervous system (CNS) disease involvement, or prior history of NCI CTCAE Grade ≥3 drug-related CNS toxicity. * Evidence of active uncontrolled viral, bacterial, or systemic fungal infection * Active SARS-CoV-2 infection, irrespective of symptoms. * History or risk of severe, chronic, untreated, or currently active autoimmune disease * Prior solid organ transplant or has had an allogenic hematopoietic stem cell transplant within the past 20 years * Pregnant, lactating, or breastfeeding
References
Publications (0)
Data not yet available