Clinical trial · Interventional
A Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive Solid Tumors
An Open-label, Multicenter, Phase I Study to Evaluate Safety, Pharmacokinetics, and Preliminary Anti-tumor Activity of RO7444973 in Participants With Unresectable and/or Metastatic MAGE-A4-positive 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): The study was terminated due to program discontinuation.
Summary
Brief summary (as posted)
This is a first-in-human, open-label, uncontrolled, multi-center, monotherapy dose-escalation and dose expansion study of RO7444973.The aim of this study is to evaluate the safety, pharmacokinetics, pharmacodynamics, and preliminary efficacy of RO7444973 in participants with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid tumors, carrying the HLA-A\*02:01 allele.
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 Tumors | Solid Neoplasm | CURATED_BROADER | 0.80 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| RO7444973 | Drug | — | UNRESOLVED |
| Tocilizumab | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Part I: Single Participant Cohort (SPC) Dose Escalation
- description
- In Part I, RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level.
- interventionNames
- Drug: RO7444973
- Drug: Tocilizumab
- type
- EXPERIMENTAL
- label
- Part II: Multiple Participant Cohort (MPC) Dose Escalation
- description
- In Part II, RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored.
- interventionNames
- Drug: RO7444973
- Drug: Tocilizumab
- type
- EXPERIMENTAL
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Key Inclusion Criteria: * Unresectable and/or metastatic solid tumors that have received standard-of-care (SOC) therapies previously and have no other SOC options available * Confirmed HLA-A\*02:01 haplotype * Confirmed MAGE-A4 expression * Radiologically measurable disease according to Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 * Life expectancy of \>/=12 weeks * Eastern Cooperative Oncology Group (ECOG) performance status of 0-1 * Absence of rapid disease progression, threat to vital organs or non-irradiated lesions \>2 cm in diameter at critical sites * No significant ongoing toxicity from prior anticancer treatment * Adequate hematological function * Adequate liver function * Adequate renal function * If applicable, willingness to use contraceptive measures. Key Exclusion Criteria: * History or clinical evidence of CNS primary tumors or metastases * Another invasive malignancy in the last 2 years * Uncontrolled hypertension * Significant cardiovascular disease * Known active or uncontrolled bacterial, viral, fungal, mycobacterial, parasitic or other infection * Current or past history of CNS disease * Dementia or altered mental status that would prohibit informed consent * Active auto-immune disease or flare within 6 months prior to start of study treatment * Expected need for regular immunosuppressive therapy or with systemic corticosteroids * Insufficient washout from prior anti-cancer therapy * Prior treatment with a bispecific T-cell engaging or adoptive cell therapy.
References
Publications (0)
Data not yet available