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Advanced or Metastatic Solid TumorsPhase 1NCT05753722

A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies

A Phase 1 study testing PRTH-101 and Pembrolizumab in people with Advanced or Metastatic Solid Tumors and Non Small Cell Lung Cancer, run by Incendia Therapeutics at 11 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
PRTH-101 and Pembrolizumab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
79 participants
Where
11 sitesUnited States
Study dates
3 Mar 2023to 2 Sep 2026
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subject must be willing and able to read, understand, and sign an Informed Consent Form.
  • Subject must be age ≥18 years.
  • Subject has metastatic or advanced, unresectable malignancy and measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 as assessed at Screening, excluding hepatocellular carcinoma, sarcomas, and gliomas.
  • Subject has a pathologically documented advanced/unresectable or metastatic cancer that is refractory to or intolerable to or the subject is unwilling or ineligible to receive standard treatment known to confer benefit or for which no standard treatment is available.
  • Subject must have an Eastern Cooperative Oncology Group performance status (PS) 0-1.
  • Subject must have a predicted life expectancy of ≥3 months.
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  • Subject must have the following laboratory values (obtained ≤14 days prior to enrollment):
  • Calculated creatinine clearance must be ≥30 mL/min by Cockcroft-Gault formula calculation
  • Total bilirubin ≤1.5 × ULN unless has known history of Gilbert's syndrome (in which case, total bilirubin must be ≤3 × ULN)
  • Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤1.5 × ULN, or ≤3 x ULN in the presence of liver metastases
  • Hemoglobin ≥9.0 g/dL
  • Platelets ≥100 × 109 cells/L 9
  • Absolute neutrophil count ≥1.5 ×10 cells/L (without the use of hematopoietic growth factors)
  • Corrected QT interval (QTc) ≤470 milliseconds (as calculated by the Fridericia correction formula)
  • Women of child-bearing potential (WOCBP) must have a negative pregnancy test within 3 days prior to first administration of PRTH-101.
  • WOCBP and males with female partners of child-bearing potential must agree to use adequate birth control throughout their participation and for 90 days following the last dose of PRTH-101.
  • Subject must be willing to adhere to the study visit schedule and the prohibitions and restrictions specified in this protocol.
  • Subject must have a site of disease amenable to biopsy and be a candidate for tumor biopsy according to the treating institution's guidelines or have archived tissue available (Section 12.3) at enrollment.
  • Subjects with sites of disease not amenable to biopsy may be considered after discussion with the Sponsor.
  • The subject is not enrolled in any other clinical trial and is not receiving other therapy directed at their malignancy.
  • The subject is willing to undergo pre-and post-treatment skin biopsies.

Who cannot join

  • Subject has received prior treatment with systemic agents, including, but not limited to, radio-immunoconjugates, antibody-drug conjugates, immune/cytokines, and monoclonal antibodies (e.g., checkpoint inhibitors) within 28 days or five half-lives of the drug, whichever is shorter.
  • Subject has ongoing toxicity from prior therapy >Grade 1 according to the CTCAE, with the following exceptions. Such exceptions must be assessed by the Investigator (and approved by the Sponsor) as not placing the subject at undue safety risk from participating in this study.
  • Alopecia, and vitiligo
  • Grade ≤2 neuropathy
  • Well-controlled hypo/hyperthyroidism or other endocrinopathies that are well controlled with hormone replacement
  • Subject has undergone a major surgery (excluding minor procedures e.g., placement of vascular access) <2 months prior to administration of PRTH-101.
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  • Subject has received radiation therapy <28 days prior to administration of PRTH-101.
  • Exception: limited (e.g., pain palliation) radiation therapy is allowed prior to and during study treatment as long as there are no acute toxicities, and the subject has measurable disease outside the radiation field.
  • Subject has undergone or is anticipated to undergo organ transplantation including allogeneic or autologous stem-cell transplantation, at any time.
  • Subject has a diagnosis of immunodeficiency, either primary or acquired.
  • Subject has received treatment with systemic steroids or any other form of immunosuppressive therapy within 14 days prior to administration of PRTH-101.
  • Exception: inhaled or topical (to include mouthwash) steroids and adrenal replacement doses are permitted in the absence of active autoimmune disease.
  • Subject has an active or prior history of autoimmune disease requiring immunosuppressive therapy. Exceptions can be made in discussion with the medical monitor.
  • Subject has a known severe intolerance to or hypersensitivity reactions to monoclonal antibodies, Fc-bearing proteins (e.g., soluble receptors or other Fc fusion proteins), or IV immunoglobulin preparations; prior history of human antihuman antibody response; known allergy to any of the study medications, their analogues, or excipients in the various formulations of any agent.
  • Subject has Central Nervous System (CNS) tumor involvement not definitively treated with surgery or radiation that is active (including evidence of cerebral edema by MRI, or progression from prior imaging study, or has had any requirement for steroids, or clinical symptoms of/from CNS metastases within 28 days prior to study treatment.
  • Subject has leptomeningeal carcinomatosis, regardless of treatment history.
  • Subject has current second malignancy at other sites (exceptions: nonmelanomatous skin cancer, adequately treated in situ carcinoma [e.g., cervical], or indolent prostate cancer under observation). A history of other malignancies is allowed as long as subject has been free of recurrence for ≥2 years, or if the subject has been treated with curative intent within the past 2 years and, in the opinion of the Investigator, is unlikely to have a recurrence.
  • Subject has active and clinically significant bacterial, fungal, or viral infection, including known Hepatitis A, B, or C or HIV (testing not required).
  • Subject has received live vaccines within the past 30 days (inactivated vaccines are allowed; seasonal vaccines should be up to date >30 days prior to administration of PRTH-101).
  • Women who are pregnant or breastfeeding.
  • History of any of the following ≤6 months before first dose:
  • Congestive heart failure New York Heart Association Grade III or IV b. Unstable angina c. Myocardial infarction d. Unstable symptomatic ischemic heart disease e. Uncontrolled hypertension despite appropriate medical therapy f. Ongoing symptomatic cardiac arrhythmias of > Grade 2 g. Symptomatic cerebrovascular events, or any other serious cardiac condition (e.g., pericardial effusion or restrictive cardiomyopathy); chronic atrial fibrillation on stable anticoagulant therapy is allowed.
  • Subject has any contraindications to the imaging assessments or other study procedures that subjects will be undergoing.
  • Subject has any medical or social condition that, in the opinion of the Investigator, might place a subject at increased risk, affect compliance, or confound safety or other clinical study data interpretation.

Trial locations and contacts

11 sites in 1 country.

11 sites in 1 country

United States11 sites

  • Mass General Cancer Center

    Boston, Massachusetts, 02114

  • Next Oncology

    Fairfax, Virginia, 22031

  • The University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • NEXT Houston

    Houston, Texas, 77054

  • Next Oncology

    Irving, Texas, 75039

  • Vanderbilt-Ingram Cancer Center

    Nashville, Tennessee, 27232

  • Yale Cancer Center

    New Haven, Connecticut, 06511

  • University of Pittsburgh Medical Center Hillman Cancer Center

    Pittsburgh, Pennsylvania, 15232

  • Providence Cancer Institute Franz Clinic

    Portland, Oregon, 97213

  • NEXT Oncology

    San Antonio, Texas, 78229

  • Honor Health Research Institute

    Scottsdale, Arizona, 85258

Other trials in United States

About this study

Official title: An Open-Label Phase 1 Dose-Escalation and Expansion Study Investigating the Safety, Pharmacokinetics, Pharmacodynamics, and Activity of PRTH-101 Alone or in Combination With Pembrolizumab in Adults With Advanced or Metastatic Solid Tumors

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.

Read the detailed description

The goal of this Open-Label Study is to evaluate the safety and tolerability of PRTH-101 alone or in combination with pembrolizumab in adults with advance or metastatic solid tumors.

PRTH-101 is a therapeutic antibody that specifically binds to and blocks DDR1, a protein expressed on tumor cells that binds collagen to make a minimally permeable physical barrier that blocks immune cells from interacting with and attacking tumor cells. These "immune cell-excluded" solid tumors are resistant to attack by the immune system (as well as other existing therapies). By disabling DDR1, the collagen fibers lose alignment and loosen, creating gaps in the tumor barrier, thus allowing T-cells to enter and naturally attack the tumor.

The main question[s] it aims to answer are:

  • to evaluate the safety and tolerability of PRTH-101 as mono therapy and in combination with pembrolizumab,
  • to determine the recommended Phase 2 dose as mono therapy and in combination with pembrolizumab,
  • to evaluate anti-tumor activity of PRTH-101 as mono therapy and in combination with pembrolizumab in selected indications
Being tested
PRTH-101, Pembrolizumab
Keywords
Non Small Cell Lung Cancer, NSCLC
Medical subject headings
Carcinoma, Non-Small-Cell Lung

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PRTH-101Biological

    PRTH-101 is a humanized immunoglobulin gamma-1 (IgG1) monoclonal antibody

  • PembrolizumabBiological

    PRTH-101 in combination with Pembrolizumab

Study groups in NCT05753722
Study groupRoleWhat they receive
PRTH-101ExperimentalMono-therapy
Receives: Biological: PRTH-101
PRTH-101 with PembrolizumabExperimentalCombo therapy
Receives: Biological: PRTH-101; Biological: Pembrolizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with PRTH-101

    To evaluate the safety of PRTH-101 as assessed by Adverse Events (AEs), including Serious Adverse Events (SAEs) and Dose Limiting Toxicities (DLTs)

    Measured: Up to 4 years

  2. Maximum Tolerated Dose

    Maximum dose level not requiring dose de-escalation under Bayesian design rules

    Measured: Up to 4 years

  3. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include the accumulation ratio.

    Measured: Up to 4 years

  4. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include PK maximum concentration (Cmax)

    Measured: Up to 4 years

  5. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include observed serum concentration (Tmax)

    Measured: Up to 4 years

  6. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include last measurable concentration (Clast),

    Measured: Up to 4 years

  7. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include time of last measurable concentration (Tlast,)

    Measured: Up to 4 years

  8. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include area under curve up to the last measurable concentration (AUClast)

    Measured: Up to 4 years

  9. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include, volume of distribution (Vd,)

    Measured: Up to 4 years

  10. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    PK parameters for Phase 1a and Phase 1b will include drug clearance (CL,)

    Measured: Up to 4 years

  11. Pharmacokinetic (PK) profile of PRTH-101 alone and in combination with pembrolizumab

    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.)

    Measured: Up to 4 years

  12. Anti-tumor activity of PRTH-101 alone and in combination with pembrolizumab

    Best overall response as assessed by iRECIST in 1c

    Measured: Up to 4 years

Secondary outcomes (20)

  1. To evaluate the incidence and persistence of anti-PRTH-101 antibody formation and its impact on the PK profile of PRTH-101

    Evaluate anti-drug antibody in serum over multiple timepoints and its impact on the PK profile of PRTH-101

    Measured: Up to 4 years

  2. To evaluate the incidence and persistence of anti- PRTH-101 antibody formation and its impact on the PK profile of PRTH-101 in combination with pembrolizumab antibody therapy

    Evaluate anti-drug antibody in serum over multiple timepoints and its impact on the PK profile of PRTH-101 in combination with pembrolizumab antibody therapy

    Measured: Up to 4 years

  3. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include the accumulation ratio

    Measured: Up to 4 years

  4. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include PK maximum concentration (Cmax)

    Measured: Up to 4 years

  5. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include observed serum concentration (Tmax)

    Measured: Up to 4 years

  6. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include last measurable concentration (Clast)

    Measured: Up to 4 years

  7. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include time of last measurable concentration (Tlast)

    Measured: Up to 4 years

  8. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include area under curve up to the last measurable concentration (AUClast)

    Measured: Up to 4 years

  9. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include volume of distribution (Vd)

    Measured: Up to 4 years

  10. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include drug clearance (CL)

    Measured: Up to 4 years

  11. To evaluate the PK of pembrolizumab

    PK parameters for Phase 1b will include the time required for plasma concentration of a drug to decrease by 50% (t1⁄2.)

    Measured: Up to 4 years

  12. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include accumulation ratio

    Measured: Up to 4 years

  13. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include PK maximum concentration (Cmax)

    Measured: Up to 4 years

  14. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include observed serum concentration (Tmax)

    Measured: Up to 4 years

  15. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include last measurable concentration (Clast)

    Measured: Up to 4 years

  16. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include time of last measurable concentration (Tlast)

    Measured: Up to 4 years

  17. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include area under curve up to the last measurable concentration (AUClast)

    Measured: Up to 4 years

  18. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b as well as Phase 1c will include volume of distribution (Vd)

    Measured: Up to 4 years

  19. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include drug clearance (CL)

    Measured: Up to 4 years

  20. To define the PK profile of PRTH-101 together with pembrolizumab

    PK parameters for Phase 1b will include the time required for plasma concentration of a drug to decrease by 50% (t1⁄2.)

    Measured: Up to 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Mar 2023
  2. Study start3 Mar 2023
  3. Primary completion2 Sep 2026
  4. Study completion2 Sep 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Masking
None (open label)
Enrolment
79 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05753722
Sponsor's protocol ID
PRTH-101-0001
Status last verified
Sep 2026
First submitted
9 Feb 2023
Last updated
28 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing PRTH-101 and Pembrolizumab in people with Advanced or Metastatic Solid Tumors and Non Small Cell Lung Cancer, run by Incendia Therapeutics at 11 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 21 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Evaluate the Adverse Events (AEs), including Serious Adverse Events (SAEs), that occur in patients treated with PRTH-101 (time frame: Up to 4 years). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05753722.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.

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