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Spots Global Cancer Trial Database for A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours

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Trial Identification

Brief Title: A Study of PM1021 (Anti-TIGIT) With or Without PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours

Official Title: A Phase I Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of PM1021 (Anti-TIGIT) Monotherapy and PM1021 in Combination With PM8001 (Anti-PD-L1/TGF-β) in Patients With Advanced Solid Tumours

Study ID: NCT05537051

Interventions

PM1021, PM8001

Study Description

Brief Summary: The purpose of this research is to assess the safety, tolerability and effectiveness of PM1021 Monotherapy and PM1021 in Combination with PM8001 in Patients with Advanced Solid Tumours. In this study, up to 30 patients will be enrolled in Australia only. Advanced solid cancers are associated with poor prognosis and pose a significant challenge for treatment strategies. Effective treatments for advanced metastatic malignancies that have failed available standard of care treatment represent a major unmet medical need. Biotheus Inc. is developing PM1021, a monoclonal anti-T cell immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains (TIGIT) antibody (IgG1) and PM8001 (a PD-L1/TGF-beta bispecific Fc fusion protein) as treatment for advanced solid tumours.

Detailed Description: This is a single-arm, open-label, Phase I study including a first-in-human study for PM1021, and the combination therapy of PM1021 with PM8001. The study will be following the accelerated titration design and the classic 3+3 design, and dose escalation will be investigated for PM1021 monotherapy (Part A) and in combination with PM8001 (Part B), respectively. In the absence of DLTs in Parts A and B, patients will continue to receive combination therapy (Part C) until disease progression, intolerable toxicity, until the patient withdraws/is withdrawn, or study completion. Up to 30 patients are planned to be enrolled. Four dose levels (150mg, 450 mg, 900 mg, and 1200 mg) of PM1021 with or without PM8001 (20 mg/kg) treatment will be explored in this study.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Contact Details

Name: Vineet Kwatra

Affiliation: Cancer Research South Australia

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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