A First-in-human Study of PRTH-101 Monotherapy +/- Pembrolizumab in Subjects With Advanced Malignancies
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorIncendia Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Sequential
Treatments tested in this trial
PRTH-101
Biological/VaccinePRTH-101 is a humanized immunoglobulin gamma-1 (IgG1) monoclonal antibody
Pembrolizumab
Biological/VaccinePRTH-101 in combination with Pembrolizumab
Treatment groups
270 Participants
are divided into 2 treatment groupsGroup A: PRTH-101Experimental treatment 1 intervention
Group B: PRTH-101 with PembrolizumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
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)
Time frame
Up to 4 years2
Maximum Tolerated Dose
Maximum dose level not requiring dose de-escalation under Bayesian design rules
Time frame
Up to 4 years3
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.
Time frame
Up to 4 years4
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)
Time frame
Up to 4 yearsSecondary outcomes
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
Time frame
Up to 4 years2
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
Time frame
Up to 4 years3
To evaluate the PK of pembrolizumab
PK parameters for Phase 1b will include the accumulation ratio
Time frame
Up to 4 years4
To evaluate the PK of pembrolizumab
PK parameters for Phase 1b will include PK maximum concentration (Cmax)
Time frame
Up to 4 yearsSponsors and contacts
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Source ClinicalTrials.gov