PT199 for Solid Tumors, Advanced Solid Tumors

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Tranquility Research, Webster, TX
Solid Tumors, Advanced Solid Tumors+27 More
PT199 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This is a first-in-human, Phase I, open-label, dose-escalation and expansion study designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PT199 (an Anti-CD73 mAb) alone and in combination with a PD-1 inhibitor, in patients with locally advanced or metastatic solid tumors that have progressed after all available standard therapy or for which standard therapy has proven to be ineffective, intolerable, or is considered inappropriate.

Eligible Conditions

  • Solid Tumors, Advanced Solid Tumors
  • Cancer of Pancreas
  • Esophageal Neoplasms Malignant
  • Non-Small Cell Lung Carcinoma (NSCLC)
  • Adenocarcinoma
  • Squamous cell carcinoma
  • Colorectal Carcinoma
  • Ovarian Cancer
  • hepatic carcinomas
  • Malignant Neoplasm of Stomach
  • Lung Cancers
  • Head and Neck Cancer
  • Breast Cancer (Triple Negative Breast Cancer (TNBC))
  • Thyroid Cancers
  • Refractory Cancer
  • Metastatic Cancers

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Study Objectives

2 Primary · 2 Secondary · Reporting Duration: Through study completion, an average of 2 years.

Day 90
Maximum Tolerated Dose (MTD), if reached.
PK Parameters.
RP2D of PT199 as a single agent and/or in combination with a PD-1 inhibitor.
Year 2
Preliminary Efficacy (assessed by the response rate by iRECIST and RECIST 1.1).

Trial Safety

Safety Progress

1 of 3

Other trials for Solid Tumors, Advanced Solid Tumors

Trial Design

3 Treatment Groups

Part A Monotherapy Dose Escalation
1 of 3
Part B Combination Therapy Dose Escalation
1 of 3
Part C Combination Therapy Dose Expansion
1 of 3
Experimental Treatment

38 Total Participants · 3 Treatment Groups

Primary Treatment: PT199 · No Placebo Group · Phase 1

Part A Monotherapy Dose Escalation
Drug
Experimental Group · 1 Intervention: PT199 · Intervention Types: Drug
Part B Combination Therapy Dose EscalationExperimental Group · 2 Interventions: PT199, Anti-PD-1 monoclonal antibody · Intervention Types: Drug, Drug
Part C Combination Therapy Dose ExpansionExperimental Group · 2 Interventions: PT199, Anti-PD-1 monoclonal antibody · Intervention Types: Drug, Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through study completion, an average of 2 years.
Closest Location: Tranquility Research · Webster, TX
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2022First Recorded Clinical Trial
1 TrialsResearching Solid Tumors, Advanced Solid Tumors
4 CompletedClinical Trials

Who is running the clinical trial?

Phanes TherapeuticsLead Sponsor
1 Previous Clinical Trials
58 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have at least one lesion as defined by RECIST V1.1 criteria for solid tumors.
Needle aspiration is insufficient.
Archival tissue is acceptable if biopsy was completed within 6 months.
You have no symptoms or signs of cancer.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.