PRTH-101 for Advanced Solid Tumors
This study is testing a new treatment called PRTH-101, either by itself or with pembrolizumab, for adults with advanced or metastatic (spread to other parts of the body) solid tumors, including non-small cell lung cancer. PRTH-101 is a special antibody designed to break down a barrier around tumors, allowing the body's immune cells to attack them more effectively. Researchers want to see how safe PRTH-101 is, what dose works best, and if it can shrink tumors. The study aims to enroll up to 270 participants.
- Study design
- This is an open-label study, meaning both you and your doctors will know which treatment you are receiving. It is testing PRTH-101 alone or in combination with pembrolizumab.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for up to 4 years to evaluate side effects, the best dose, and how the drug moves through the body.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
At a glance
Conditions
NCT05753722
Where you'd take part
This study runs at 11 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.
Honor Health Research Institute
Scottsdale, Arizonano site contact published
Recruiting
Mass General Cancer Center
Boston, Massachusettsno site contact published
Recruiting
NEXT Houston
Houston, Texasno site contact published
Recruiting
Next Oncology
Irving, Texasno site contact published
Recruiting
Next Oncology
Fairfax, Virginiano site contact published
Recruiting
NEXT Oncology
San Antonio, Texasno site contact published
Recruiting
Providence Cancer Institute Franz Clinic
Portland, Oregonno site contact published
Recruiting
The University of Texas MD Anderson Cancer Center
Houston, Texasno site contact published
Recruiting
Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.
Study leadership
- Joseph Paul Eder, MD · STUDY_CHAIR · Incendia Therapeutics
Who to contact
Opens a ready-to-send draft in your own email app — review before sending.
What this trial measures
- Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with PRTH-101Up to 4 years
To evaluate the safety of PRTH-101 as assessed by Adverse Events (AEs), including Serious Adverse Events (SAEs) and Dose Limiting Toxicities (DLTs)
- Maximum Tolerated DoseUp to 4 years
Maximum dose level not requiring dose de-escalation under Bayesian design rules
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include the accumulation ratio.
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include PK maximum concentration (Cmax)
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include observed serum concentration (Tmax)
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include last measurable concentration (Clast),
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include time of last measurable concentration (Tlast,)
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include area under curve up to the last measurable concentration (AUClast)
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include, volume of distribution (Vd,)
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include drug clearance (CL,)
- Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
PK parameters for Phase 1a and Phase 1b will include the time required for plasma concentration of a drug to decrease by 50% (t1⁄2.)
- Anti-tumor activity of PRTH-101 alone and in combination with pembrolizumabUp to 4 years
Best overall response as assessed by iRECIST in 1c