A Study to Determine the Effect of CT3001 in Patients With Advanced Solid Tumors
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCrossignal Therapeutics, Inc.
About this trial
This is an FIH, multicenter, open-label, dose escalation and dose expansion/dose optimization study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2b. Phase 1 will be a standard 3+3 dose escalation and dose finding study in patients with advanced solid tumors for whom there is no available therapy (or patients are not candidates for such therapy) for the assessment of DLTs at up to 7 dose levels of CT3001. Phase 2b is a dose finding/dose optimization study of CT3001 in combination with SOC chemotherapy (FOLFOX) to evaluate the safety and preliminary efficacy of CT3001 in patients with advanced CRC who are eligible for re-engaging FOLFOX-based chemotherapy.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Able to give voluntary informed consent and understand the study and are willing to follow and complete all the test procedures.
Aged ≥ 18 years (or adult age as per local regulations).
Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors that are refractory to standard therapy, or for whom no standard therapy exists. Note: In Phase 2b, only participants with advanced CRC who are eligible for re-engaging FOLFOX will be enrolled.
Has measurable disease per RECIST Version 1.1. that was not in a prior radiation or other locally treated area unless imaging-based progression has been clearly documented following radiation or other local therapy.
Disqualifiers
During Phase 1 Dose Escalation, receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy [excluding the following small-area radiotherapy for bone metastasis], endocrine therapy, antitumor traditional Chinese Medicine), except during Phase 2b, Standard Care Chemotherapy (FOLFOX-based regimen) for advanced CRC patients is allowed.
Use of other IP within 5 half-lives of the product (if the IP is a small molecule) or anti-cancer investigational medical device within two weeks prior to the first administration of CT3001. Prior use of investigational monoclonal antibody IP can be permitted upon obtaining an approval from the Sponsor. Use of these investigational IP or devices are not permitted for the duration of treatment with CT3001.
Evidence of severe or uncontrolled systemic diseases, infection, or laboratory finding that in the view of the PI or designee makes it undesirable for the patient to participate in the trial.
Females who are pregnant or nursing, or any participant who is planning to become pregnant (self or partner) at any time during the study, including the Follow-up Period.
Trial design
Design model
Sequential
Treatments tested in this trial
CT3001
DrugCT3001 is an Oral Solution, with active pharmaceutical agent, a small molecule inhibitor of GPR35, formulated with PEG 400, strawberry flavor, and anhydrous ethanol.
FOLFOX (5-fluorouracil, Leucovorin, Oxaliplatin)
DrugFOLFOX will be administered Q2W per institutional standard.
Treatment groups
78 Participants
are divided into 10 treatment groups10
Treatment groupsSee each treatment group below.
Group A: CT3001 50mgExperimental treatment 1 intervention
Group B: CT3001 100mgExperimental treatment 1 intervention
Group C: CT3001 200mgExperimental treatment 1 intervention
Group D: CT3001 300mgExperimental treatment 1 intervention
Group E: CT3001 500mgExperimental treatment 1 intervention
Group F: CT3001 700mgExperimental treatment 1 intervention
Group G: CT3001 1000mgExperimental treatment 1 intervention
Group H: CT3001 400mgExperimental treatment 2 interventions
Group I: CT3001 600mgExperimental treatment 2 interventions
Group J: CT3001 800mgExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Incidence of dose-limiting toxicities (DLTs).
Time frame
Up to approximately 2 years2
Incidence and severity of serious adverse events (SAEs).
Time frame
Up to approximately 2 years3
Incidence and severity of treatment-emergent adverse events (TEAEs) .
Time frame
Up to approximately 2 yearsSecondary outcomes
1
Objective response rate (ORR) and/or clinical benefit rate (CBR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.
Time frame
Up to approximately 2 years2
Time to progression (TTP), duration of response (DoR), Duration of Clinical Benefit (DoCB), and progression-free survival (PFS).
Time frame
Up to approximately 2 years3
Plasma CT3001 half life (t1/2) calculated following a single dose of CT3001.
Time frame
Up to approximately 2 years4
Plasma CT31001 maximum concentration (Cmax) calculated following a single dose of CT3001.
Time frame
Up to approximately 2 yearsOther outcomes
1
Biomarker evaluations in the blood and/or plasma (e.g. tumor necrosis factor alpha [TNF-α], interferon gamma [IFN-γ], transforming growth factor beta 1 [TGF-β1], and interleukin [IL]-10.
Time frame
Up to approximately 2 yearsSponsors and contacts
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Source ClinicalTrials.gov