A Study to Determine the Effect of CT3001 in Patients with Advanced Solid Tumors

NCT06598007 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CT3001-101
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

Brief Summary

This is an FIH, multicenter, open-label, dose escalation and dose expansion study of CT3001, which will be conducted in 2 phases: Phase 1 and Phase 2a. 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 6 dose levels of CT3001. Phase 2a is a dose expansion study to evaluate the preliminary efficacy of CT3001 in patients with advanced CRC or PDAC.

Conditions

Solid Tumor, Adult; Colorectal Cancer; Pancreatic Ductal Adenocarcinoma

Outcome Measures

Primary Outcomes (3)

• Incidence of dose-limiting toxicities (DLTs).

  Up to approximately 2 years

• Incidence and severity of serious adverse events (SAEs).

  Up to approximately 2 years

• Incidence and severity of treatment-emergent adverse events (TEAEs) .

  Up to approximately 2 years

Secondary Outcomes (10)

• Objective response rate (ORR) and/or clinical benefit rate (CBR) per Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.1.

  Up to approximately 2 years

• Time to progression (TTP), duration of response (DoR), Duration of Clinical Benefit (DoCB), and progression-free survival (PFS).

  Up to approximately 2 years

• Plasma CT3001 half life (t1/2) calculated following a single dose of CT3001.

  Up to approximately 2 years

• Plasma CT31001 maximum concentration (Cmax) calculated following a single dose of CT3001.

  Up to approximately 2 years

• Plasma CT3001 time to maximum concentration (tmax) calculated following a single dose of CT3001.

  Up to approximately 2 years

Other 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.

  Up to approximately 2 years

Study Arms (6)

CT3001 50mg

EXPERIMENTAL

Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.

Drug: CT3001

CT3001 100mg

EXPERIMENTAL

Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.

Drug: CT3001

CT3001 200mg

EXPERIMENTAL

Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.

Drug: CT3001

CT3001 300mg

EXPERIMENTAL

Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.

Drug: CT3001

CT3001 500mg

EXPERIMENTAL

Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.

Drug: CT3001

CT3001 700mg

EXPERIMENTAL

Participants will be administered CT3001 oral solution after a meal (within 15 minutes) at Cycle 0 Day 1 and repeated daily dosing for 21 days in ongoing cycles.

Drug: CT3001

Interventions

CT3001 DRUG

CT3001 is an Oral Solution, with active pharmaceutical agent, a small molecule inhibitor of GPR35, formulated with PEG 400, strawberry flavor, and anhydrous ethanol.

CT3001 100mg; CT3001 200mg; CT3001 300mg; CT3001 500mg; CT3001 50mg; CT3001 700mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 2a, only participants with locally advanced CRC or PDAC that are refractory to standard therapy, or for whom no standard therapy exists, 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.
• Life expectancy ≥ 3 months, in the opinion of the PI or designee.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Adequate hematologic, liver, and kidney function as follows:
• Bone marrow reserve:
• Absolute neutrophil count ≥ 1.5 × 10\^9/L without growth factor support in the 2 weeks prior to study entry.
• Hemoglobin ≥9.0 g/dL without transfusion, growth factor support, or other supportive medication in the 2 weeks prior to study entry.
• Platelet count ≥ 75 × 10\^9/L without transfusion in 2 weeks prior to study entry.
• Hepatic function:
• Serum TBIL \< 1.5 × ULN.
• AST and ALT \< 3 × ULN.
• Renal function:

You may not qualify if:

• Receiving concurrent anticancer treatment (including chemotherapy, targeted drugs, radiotherapy \[excluding the following small-area radiotherapy for bone metastasis\], endocrine therapy, antitumor traditional Chinese Medicine).
• 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.
• Has had major surgery or significant traumatic injury within 4 weeks of start of CT3001; participants have not recovered from the side effects of any major surgery (defined as requiring general anesthesia) or participant might require major surgery during the course of the study.
• Has a prolonged QT interval corrected by Fredericia's formula (QTcF interval) of \> 470 ms (determined by average of 3 readings on triplicate 12-lead ECG) or has a history of additional risk factors for Torsade de Pointes (e.g., heart failure, hypokalemia, family history of long-QT syndrome) or current use of medications that prolong the QTcF interval.
• Any psychiatric, psychological, familial or geographical condition that, in the judgment of the PI or designee, may interfere with the treatment and follow-up, affect compliance or place the participant at high risk of treatment-related complications will be excluded.
• Blood donation or significant blood loss within 60 days prior to the first administration of CT3001.
• History of severe allergic or anaphylactic reactions, or sensitivity to the CT3001 or its constituents.
• Vaccination with a live vaccine within 4 weeks prior to the first administration of CT3001.
• Exposure to any significantly immune suppressing drug (including experimental therapies as part of a clinical study) within 5 half-lives of the product prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.
• Use of any medications with a narrow therapeutics index that are sensitive substrates of and metabolized mainly through CYP2C8 within 5-half-lives of the products prior to the first administration of CT3001; these medications will not be permitted for the duration of treatment with CT3001.
• Use of any gastric acid reducing agents during the time period between 6 hours prior to and 2 hours after the administration of CT3001.
• Positive test for hepatitis C antibody (HCV), hepatitis B surface antigen (HBsAg), or human immunodeficiency virus (HIV) antibodies (HIV-1/-2) at Screening, unless the participant meets 1 of the following criteria:
• Has chronic HCV infection but has completed curative antiviral treatment (note: patients may be HCV antibody positive but must be HCV RNA negative to be eligible).

Sponsors & Collaborators

• Crossignal Therapeutics, Inc.: lead

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Zhi (Zak) Liang Chu, Ph.D.

  Crossignal Therapeutics

  STUDY CHAIR

Central Study Contacts

Can Zhang

CONTACT

413-932-9263; czhang@crossignaltherapeutics.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 9, 2024
• First Posted: September 19, 2024
• Study Start: September 20, 2024
• Primary Completion (Estimated): June 20, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: November 4, 2024

Record last verified: 2024-11

Locations

US (1)