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Clinical Trials/NCT06005740
NCT06005740Active, not recruitingPhase 1

A Phase 1, First in Human Study of TORL-4-500 in Patients With Advanced Cancer

TORL Biotherapeutics, LLC10 sites in 2 countries70 target enrollmentStarted: December 4, 2023Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 1
Status
Active, not recruiting
Enrollment
70
Locations
10
Primary Endpoint
Incidence and severity of adverse events and serious adverse events
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar TrialsRelated News

Study Overview

Brief Summary

This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-4-500 in patients with advanced cancer.

For Part 1, any advanced or metastatic solid tumor malignancy will be evaluated including, for example, adrenocortical carcinoma (ACC).

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Sequential
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Advanced solid tumor
  • •Measurable disease, per RECIST v1.1
  • •Eastern Cooperative Oncology Group (ECOG) performance status 0-1
  • •Adequate organ function

Exclusion Criteria

  • •Has not recovered [recovery is defined as NCI CTCAE, version 5.0, grade ≤1] from the acute toxicities of previous therapy, except treatment-related alopecia or laboratory abnormalities otherwise meeting eligibility requirements
  • •Received prior chemotherapeutic, investigational, or other therapies for the treatment of cancer within 14 days with small molecule and within 28 days with biologic before the first dose of TORL-4-500
  • •Progressive or symptomatic brain metastases
  • •Serious, uncontrolled medical disorder, nonmalignant systemic disease, or active, uncontrolled infection
  • •History of significant cardiac disease
  • •History of myelodysplastic syndrome (MDS) or AML
  • •History of another cancer within 3 years before Day 1 of study treatment, with the exception of basal or squamous cell carcinoma of the skin that has been definitively treated. A history of other malignancies with a low risk of recurrence, including appropriately treated ductal carcinoma in situ (DCIS) of the breast and prostate cancer with a Gleason score less than or equal to 6, are also not excluded
  • •If female, is pregnant or breastfeeding

Arms & Interventions

Monotherapy Dose Dose Finding - Part 1

Experimental

TORL-4-500 iv once every 3 weeks

Intervention: TORL-4-500 (Drug)

Expansion as Monotherapy - Part 2

Experimental

TORL-4-500 iv once every 3 weeks

Intervention: TORL-4-500 (Drug)

Outcomes

Primary Outcomes

Incidence and severity of adverse events and serious adverse events

Time Frame: up to 2 years

Incidence and severity of adverse events, serious adverse events, according to NCI-CTCAE Version 5.0

Maximum Tolerated Dose (MTD)

Time Frame: 28 Days

Highest administered dose with \< 33% participants experiencing dose limiting toxicity (DLT) in the first 6 DLT evaluable participants

Recommended Phase 2 Dose (RP2D)

Time Frame: up to 2 years

Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data

Secondary Outcomes

  • Objective Response Rate (ORR)(up to 2 years)
  • Duration of Response (DOR)(up to 2 years)
  • Progression Free Survival (PFS)(up to 2 years)
  • Time to Response (TTR)(up to 2 years)
  • 1 Year Overall Survival (1YOS)(1 year)
  • 2 Year Overall Survival (2YOS)(2 years)
  • Number of anti-drug antibody (ADA) Positive Participants(up to 2 years)
  • Maximum Serum Concentration of TORL-4-500 (Cmax)(21 days)
  • Minimum Serum Concentration of TORL-4-500 (Cmin)(21 days)
  • Maximum Serum Concentration of TORL-4-500 at Steady State (Cmax,ss)(63 days)
  • Minimum Serum Concentration of TORL-4-500 at Steady State (Cmin,ss)(63 days)
  • Time of Maximum Serum Concentration of TORL-4-500 (Tmax)(21 days)
  • Time of Minimum Serum Concentration of TORL-4-500 (Tmin)(21 days)
  • Time of Minimum Serum Concentration of TORL-4-500 at Steady State (Tmin,ss)(63 days)
  • Terminal Half-life (t1/2) of Serum TORL-4-500-ADC(63 days)
  • Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-4-500(21 days)
  • Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-4-500(63 days)
  • Apparent volume of distribution during the terminal phase (Vz) of TORL-4-500(63 days)
  • Clearance (CL) of TORL-4-500(63 days)
  • Accumulation ratio (Rac) of TORL-4-500(63 days)

Investigators

Sponsor Class
Industry
Responsible Party
Sponsor

Study Sites (10)

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