An Early Phase Trial of RPTR-1-201 in Advanced Solid Tumors
ConditionAdvanced Malignant Solid Tumor
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorRepertoire Immune Medicines
About this trial
This is an early phase trial designed to evaluate the safety, tolerability, and preliminary antitumor activity of RPTR-1-201 in adults with advanced solid tumors. The trial includes dose escalation and dose expansion parts and will evaluate RPTR-1-201 as monotherapy and in combination with an anti-PD-1 monoclonal antibody.
Eligibility criteria
Qualifiers
Histologically or cytologically confirmed locally advanced or metastatic solid tumors that is not amenable to curative treatment.
At least one measurable lesion per RECIST v1.1 as assessed by the investigator.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
Adequate organ function as defined in the trial protocol.
Disqualifiers
History of another malignancy within 3 years before the first dose of trial intervention, with the exception of malignancies considered cured and not expected to require active therapy (for example, certain skin cancers or in situ malignancies) per protocol.
Known active leptomeningeal disease or uncontrolled central nervous system metastases.
Active, clinically significant, autoimmune diseases requiring systemic immunosuppressive therapy.
Prior allogenic organ transplantation
Trial design
Treatments tested in this trial
- RPTR-1-201
- PD-1 / PD-L1 monoclonal antibody
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov