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Closed (no longer recruiting)Last updated: 31 January 2024

This phase I dose escalation and dose expansion study is evaluating a new cancer drug (RO7444973) in people with inoperable or metastatic solid cancersAn 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

Clinical summary

Summary

This trial has three parts, and is seeking to learn more about RO7444973 in people with unresectable and/or metastatic melanoma-associated antigen A4 (MAGE-A4)-positive, solid cancers, carrying the HLA-A*02:01 allele. In Part I (Single Participant Cohort Dose Expansion), RO7444973 is administered intravenously (IV) every 3 weeks (Q3W) at a fixed dose in a single participant per dose level. In Part II (Multiple Participant Cohort Dose Escalation), RO7444973 is administered IV Q3W at a fixed dose in multiple participants per dose level. Step-up dosing may also be explored. In Part III (Recommended Phase 2 Dose Expansion), a recommended phase 2 dose and dosing regimen will be further investigated. In all parts, Tocilizumab will be used as rescue therapy, in case of clinical presentation of cytokine release syndrome (CRS). Tocilizumab solution for infusion will be administered intravenously at 8 mg/kg for participants >/= 30 kg or at 12 mg/kg for participants < 30 kg.

Conditions

This trial is treating patients with solid cancers that are melanoma-associated antigen A4 (MAGE-A4)-positive, and are carrying the HLA-A*02:01 allele.

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I

More information

Trial Identifiers

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Trial sponsor

Hoffmann-La Roche

Scientific Title

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

Eligibility

Inclusion

  • 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.

Exclusion

  • 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.

Inclusion

  • You have been diagnosed with cancer, but have not received any treatment.
  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • Your cancer has not spread to other parts of the body.
  • Your cancer has spread to other parts of the body.

Exclusion

  • You have been diagnosed with a prior or secondary type of cancer.
  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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