A Study Evaluating the Safety and Efficacy of AUR107 in Patients With Relapsed Advanced Malignancies (SHAKTI-1)

Recruiting Phase 1 Interventional Study
Relapsed Malignant Solid Neoplasm
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
50 (estimated)
Sponsor
Aurigene Discovery Technologies Limited · Industry
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About This Trial

An open-label, first-in-human, Phase 1 study in adult patients with relapsed advanced malignancies will be done to assess AUR107 safety, tolerability, pharmacokinetics, pharmacodynamics, and optimal biological dose.

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Males and females ≥ 18 years of age. 2. Eastern Cooperative Oncology Group (ECOG) Performance status of 0 or 1. 3. Acceptable bone marrow and organ function at screening as described below: 1. ANC ≥ 1500/μL (without WBC growth factor support) 2. Platelet count ≥ 100,00…
Contacts

Suchit Kumbhare

+91 8104730078

suchit_k@aurigene.com

CONTACT

Suresh Oduru

+91 9866225593

suresh_o@aurigene.com

CONTACT