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RecruitingLast updated: 2 April 2024

This phase I/II study is trying to determine how safe and effective, and what the appropriate dose level of a new cancer drug (LM-108) alone, or in combination with targeted therapy (an Anti-PD-1 Antibody) in people with solid cancersA Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours

Clinical summary

Summary

This study has two arms, and each arm has a dose escalation phase and a dose expansion phase. In Arm A, participants will receive LM-108 as monotherapy, administered intravenously. In Am B, participants will receive LM-108 in combination with an Anti-PD-1 Antibody, both administered intravenously.

Conditions

This trial is treating patients with advanced solid cancers

Cancer

Multi-Cancer Multi-Cancer

Age

People18+

Phase

I/II

More information

Trial Identifiers

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Trial sponsor

LaNova Australia Pty Limited

Scientific Title

A Phase I/II, First-in-Human (FIH), Open-Label, Dose Escalation and Expansion Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy of LM-108 as a Single Agent or in Combination With Anti-PD-1 Antibody in Subjects With Advanced Solid Tumours

Eligibility

Inclusion

  1. Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
  2. Histological or cytological confirmation of recurrent or refractory advanced solid tumours, and have progressed on standard therapy, or are intolerable for available standard therapy, or there is no available standard therapy.
  3. At least one measurable disease for expansion cohorts per Response Evaluation Criteria in Solid Tumours (RECIST) v1.1.
  4. Subjects must show appropriate organ and marrow function in laboratory examinations within 7 days prior to the first dose

Exclusion

  1. Any adverse event from prior anti-tumour therapy has not yet recovered to ≤grade 1 of CTCAE v5.0
  2. Uncontrolled tumour-related pain
  3. Known central nervous system (CNS)
  4. Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures
  5. Use of inhaled corticosteroids
  6. Known history of autoimmune disease
  7. Use of any live attenuated vaccines within 28 days
  8. Have severe cardiovascular disease
  9. Uncontrolled or severe illness
  10. History of immunodeficiency disease
  11. Active malignancies which are likely to require the treatment.
  12. Child-bearing potential female
  13. Have psychiatric illness or disorders

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Inclusion

  • You have had treatment but your cancer has gotten worse or has not responded to the treatment you have been given.
  • You have had treatment, but your cancer has come back.

Exclusion

  • 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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