A Phase 1 Study of JMT108 in Participants With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorConjupro Biotherapeutics, Inc.
About this trial
The goal of this clinical trial is to test JMT108, a type of drug called a bispecific antibody in adult patients with locally advanced or metastatic solid tumors.
The main questions it aims to answer are:
* To assess the safety and tolerability of JMT108 at increasing doses and determine the dose and schedule to be used in the second part of the study (Phase 1a) * To assess effectiveness of JMT108 in participants with locally advanced or metastatic tumors (Phase 1b) * To evaluate how quickly JMT108 is metabolized by the body (pharmacokinetics or PK) * To evaluate if antibodies to the study drug develop (immunogenicity) * To evaluate preliminary efficacy to the drug * To explore the pharmacodynamic (PD) characteristics of JMT108 * To explore the correlation between biomarker levels and preliminary efficacy
Participants will:
* Provide written informed consent * Undergo screening tests to ensure they are eligible for study treatment * Attend all required study visits and receive JMT108 by intravenous injection every 2 weeks until the study doctor determines study treatment should be stopped, based on how well a participant is doing on treatment * Be followed for progression every 3 months for up to 2 years
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age ≥18 years
Participants with histologically or cytologically confirmed locally advanced or metastatic solid tumors who are unresponsive or intolerant to all standard of care or have no standard of care available
At least one evaluable tumor lesion according to RECIST v1.1.
ECOG performance status score ≤2.
Disqualifiers
Active central nervous system metastases and/or leptomeningeal metastases
AEs from prior therapy which have not recovered to Grade ≤1 or baseline as per NCI CTCAE v5.0
Any other unapproved investigational drugs or treatments within 4 weeks prior to the first dose of the investigational drug (C1D1).
Nitrosoureas or mitomycin C within 6 weeks prior to the first dose of the investigational drug;
Trial design
Design model
Sequential
Treatments tested in this trial
JMT108
DrugAdministered by intravenous injection
Treatment groups
270 Participants
are divided into 3 treatment groupsGroup A: Phase 1a Dose EscalationExperimental treatment 1 intervention
Group B: Phase 1a Dose ExpansionExperimental treatment 1 intervention
Group C: Phase 1b Cohort ExpansionExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Number of participants with Dose Limiting Toxicities as assessed by NCI CTCAE v5.0 (excluding cytokine release syndrome, CRS).
To evaluate the safety and tolerability of JMT108 to determine the dose and schedule to be used in phase 1b.
Time frame
through study completion, an average of 1 year2
Number of participants with Tumor Response as assessed by RECIST version 1.1 criteria
To evaluate preliminary efficacy of JMT108 injection as monotherapy in participants with advanced malignant tumors.
Time frame
through study completion, an average of 1 yearSecondary outcomes
1
JMT108 Pharmacokinetics: Area under the concentration time curve over the dosing interval
JMT 108 Pharmacokinetics: Area under the concentration time curve over the dosing interval.
Time frame
through study completion, an average of 1 year2
JMT108 Pharmacokinetics: Elimination half-life (t1/2)
JMT108 Pharmacokinetics: Elimination half-life (t1/2)
Time frame
through study completion, an average of 1 year3
JMT 108 Pharmacokinetics: Clearance (CL)
JMT108 Pharmacokinetics: Clearance (CL)
Time frame
through study completion, an average of 1 year4
JMT108 Objective response rate (ORR)
ORR is defined as the proportion of patients in whom a complete response (CR) or partial response (PR), per Response Evaluation Criteria in Solid Tumors (RECIST) v 1.1 is observed as best overall response
Time frame
through study completion, an average of 1 yearOther outcomes
1
JMT 108 Pharmacodynamics: Changes in immune cell levels: CD8+ T cells, CD4+ T cells, NK cells, PD-1+ immune cells
JMT 108 Pharmacodynamics: Changes in immune cell levels: CD8+ T cells, CD4+ T cells, NK cells, PD-1+ immune cells to explore the PD characteristics of JMT108 Injection
Time frame
through study completion, an average of 1 year2
JMT 108 Pharmacodynamics: Changes in cytokine levels (including but not limited to): IL-6, IL-8, TNF-α, IFN-γ
Changes in cytokine levels (including but not limited to): IL-6, IL-8, TNF-α, IFN-γ to explore the PD characteristics of JMT108 Injection
Time frame
through study completion, an average of 1 year3
JMT108 Correlatives: Correlation of baseline PD-L1 expression with anti-tumor activity
Correlation of baseline PD-L1 expression with anti-tumor activity to explore the correlation between biomarker levels and preliminary efficacy
Time frame
through study completion, an average of 1 yearSponsors and contacts
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Source ClinicalTrials.gov