NCT05156866
Active, not recruiting
Phase 1
A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-ADC in Participants With Advanced Cancer
TORL Biotherapeutics, LLC12 sites in 2 countries163 target enrollmentStarted: February 2, 2022Last updated:
InterventionsTORL-2-307-ADC
DrugsTORL-2-307-ADC
Overview
- Phase
- Phase 1
- Status
- Active, not recruiting
- Sponsor
- TORL Biotherapeutics, LLC
- Enrollment
- 163
- Locations
- 12
- Primary Endpoint
- Recommended Phase 2 Dose (RP2D)
Overview
Brief Summary
This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-ADC in patients with advanced cancer
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-2-307-ADC
- •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-2-307-ADC
Intervention: TORL-2-307-ADC (Drug)
Expansion as Monotherapy - Part 2
Experimental
TORL-2-307-ADC
Intervention: TORL-2-307-ADC (Drug)
Outcomes
Primary Outcomes
Recommended Phase 2 Dose (RP2D)
Time Frame: up to 2 years
Based on the maximum tolerated dose, cumulative safety, and pharmacokinetic data
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
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-2-307-ADC (Cmax)(21 days)
- Minimum Serum Concentration of TORL-2-307-ADC (Cmin)(21 days)
- Maximum Serum Concentration of TORL-2-307-ADC at Steady State (Cmax,ss)(63 days)
- Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Cmin,ss)(63 days)
- Time of Maximum Serum Concentration of TORL-2-307-ADC (Tmax)(21 days)
- Time of Minimum Serum Concentration of TORL-2-307-ADC (Tmin)(21 days)
- Time of Minimum Serum Concentration of TORL-2-307-ADC at Steady State (Tmin,ss)(63 days)
- Terminal Half-life (t1/2) of Serum TORL-2-307-ADC(63 days)
- Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-2-307-ADC(21 days)
- Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-ADC(63 days)
- Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-ADC(63 days)
- Clearance (CL) of TORL-2-307-ADC(63 days)
- Accumulation ratio (Rac) of TORL-2-307-ADC(63 days)
Investigators
Study Sites (12)
Loading locations...
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