Clinical trial NCT05159440: First in Human Study of TORL-2-307-MAB in Participants With Advanced Cancer
Official title: A Phase 1, First in Human, Dose-Escalation Study of TORL-2-307-MAB in Participants With Advanced Cancer
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Advanced Solid Tumor
Gastric Cancer
Pancreas Cancer
Gastroesophageal Junction Adenocarcinoma
Keywords: claudin18.2
Lead sponsor: TORL Biotherapeutics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Translational Research in Oncology
First posted: 2021-12-16
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: This first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and antitumor activity of TORL-2-307-MAB in patients with advanced cancer


Eligibility criteria: 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-MAB
* 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

Primary outcomes:
measure: Incidence and severity of adverse events and serious adverse events
timeFrame: up to 2 years
measure: Maximum Tolerated Dose (MTD)
timeFrame: 28 Days
measure: Recommended Phase 2 Dose (RP2D)
timeFrame: up to 2 years
Secondary outcomes:
measure: Objective Response Rate (ORR)
timeFrame: up to 2 years
measure: Duration of Response (DOR)
timeFrame: up to 2 years
measure: Progression Free Survival (PFS)
timeFrame: up to 2 years
measure: Time to Response (TTR)
timeFrame: up to 2 years
measure: 1 Year Overall Survival (1YOS)
timeFrame: 1 year
measure: 2 Year Overall Survival (2YOS)
timeFrame: 2 years
measure: Number of anti-drug antibody (ADA) Positive Participants
timeFrame: up to 2 years
measure: Maximum Serum Concentration of TORL-2-307-MAB (Cmax)
timeFrame: 21 days
measure: Minimum Serum Concentration of TORL-2-307-MAB (Cmin)
timeFrame: 21 days
measure: Maximum Serum Concentration of TORL-2-307-MAB at Steady State (Cmax,ss)
timeFrame: 63 days
measure: Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Cmin,ss)
timeFrame: 63 days
measure: Time of Maximum Serum Concentration of TORL-2-307-MAB (Tmax)
timeFrame: 21 days
measure: Time of Minimum Serum Concentration of TORL-2-307-MAB (Tmin)
timeFrame: 21 days
measure: Time of Minimum Serum Concentration of TORL-2-307-MAB at Steady State (Tmin,ss)
timeFrame: 63 days
measure: Terminal Half-life (t1/2) of Serum TORL-2-307-MAB
timeFrame: 63 days
measure: Area under the Serum Concentration-Time curve from the time of dosing to the last measurable concentration (AUClast) for TORL-2-307-MAB
timeFrame: 21 days
measure: Area under the Serum Concentration-Time curve from the time of dosing extrapolated to time infinity (AUCinf) for TORL-2-307-MAB
timeFrame: 63 days
measure: Apparent volume of distribution during the terminal phase (Vz) of TORL-2-307-MAB
timeFrame: 63 days
measure: Clearance (CL) of TORL-2-307-MAB
timeFrame: 63 days
measure: Accumulation ratio (Rac) of TORL-2-307-MAB
timeFrame: 63 days
Other outcomes:
Locations:
city: Fullerton
country: United States
facility: Providence St. Jude Medical Center
state: California
city: Los Angeles
country: United States
facility: UCLA - JCCC Clinical Research Unit
state: California
city: Torrance
country: United States
facility: Torrance Memorial Medical
state: California
city: Fort Wayne
country: United States
facility: Fort Wayne Medical Oncology and Hematology
state: Indiana
city: Saint Louis
country: United States
facility: Washington University School of Medicine-Siteman Cancer Center
state: Missouri
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
city: Seoul
country: Korea, Republic of
facility: Severance Hospital, Yonsei University Health System
city: Seoul
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
Study officials:
affiliation: TORL Biotherapeutics, LLC
name: Stephen Letrent, PharmD, PhD
role: STUDY_DIRECTOR
References: