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RecruitingLast updated:1 September 2023

LM302: This phase I/II trial is evaluating how safe and tolerable a new targeted therapy (LM-302) is when combined with immunotherapy (toripalimab) in people with advanced solid cancersA Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination With Toripalimab in Patients With Advanced Solid Tumors

Clinical summary

Summary

This study has two phases: Dose Escalation and Dose Expansion. The Dose Escalation phase has two parts: Part 1a and Part 1b. In Dose Escalation Part 1a, participants will receive LM-302 as monotherapy in escalating doses using an accelerated titration combined with traditional 3+3 design. LM-302 is given via intravenous infusion (IV) on day 1 every 3 weeks. In Dose Escalation Part 1b, participants will receive LM-302 in escalating doses (via IV on Day 1 every 3 weeks) in combination with a fixed dose of Toripalimab (given via IV on Day 1 every 3 weeks). In the Dose Expansion phase, the study investigators will select appropriate dose(s) and/or cancer types.

Age

People18+

Phase

I/II

Trial Acronym

LM302

More information

Trial Identifiers

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Commercial Sponsor

LaNova Australia Pty Limited

Scientific Title

A Phase I/II, Open-Label, Multiple Centre Clinical Study to Evaluate the Safety, Tolerability, Pharmacokinetics, Immunogenicity and Preliminary Efficacy of LM- 302 in Combination With Toripalimab in Patients With Advanced Solid Tumors

Eligibility

Inclusion

  • You have certain types of non-cancer medical conditions.
  • You have been diagnosed with a prior or secondary type of cancer.
  • You have had certain treatments, surgical procedures or drugs.
  • You have previously been treated (or are currently being treated) on a clinical trial.

Exclusion

  • 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.
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Clinical trials have complex eligibility criteria.

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