A First-in-human (FIH), Phase I Study of PTX-912 in Patients with Locally Advanced/Metastatic Solid Tumors

Part of paid clinical trials in Duarte, California.

Sponsor
Proviva Therapeutics, Inc.
Study ID
NCT06190886
Phase
PHASE1
Status
Recruiting
Apply to this trial

Conditions

  • Advanced Cancer
  • Metastatic Cancer
  • Solid Tumor

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PTX-912 — DRUG
    Investigation Product Monotherapy

Study Details

The goal of this clinical trial is to evaluate the safety and tolerability of escalating doses of PTX-912 in patients with locally advanced or metastatic solid tumors. To evaluate the PK and immunogenicity profile of PTX-912. To evaluate the preliminary anti-tumor activity of PTX-912. Participants will be treated with PTX-912 via iv infusion, every 2 weeks until progression of disease, unacceptable toxicity, or 12 months of total study therapy.

Key Dates

Start date
Jun 11, 2024
Status verified
Nov 2024
Primary completion
May 14, 2026
Completion
Jul 24, 2026

Study Design

Enrollment
26 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: PTX-912
    Single or multiple ascending dose of PTX-912

Primary Outcome Measure

DLTs (dose limiting toxicity) [ Time Frame: within 28 days ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope National Medical CenterDuarteCalifornia91010
Principal Investigator Yan Xing, MD., M.S, Ph.D
[email protected]
626-218-3582
University of MiamiMiamiFlorida33136
Manager Research Support Phase 1, Nailet Real Bestard, M.S.
[email protected]
305-243-8173
Nebraska Cancer Specialists (NCS)OmahaNebraska68130
Director of Clinical Research
[email protected]
402-955-2691

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By research site
City of Hope National Medical Center· Duarte, CAUniversity of Miami· Miami, FLNebraska Cancer Specialists (NCS)· Omaha, NE

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