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A Study of TORL-5-700 in Relapsed/Refractory Non Hodgkin's Lymphoma

ConditionHistologically Confirmed Relapsed or Refractory B-cell Non-Hodgkin Lymphoma
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTORL Biotherapeutics, LLC

About this trial

A Phase 1/2 study to evaluate safety, tolerability, and anticancer activity of TORL-5-700 as a monotherapy and in combination in R/R NHL

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Confirmed B-NHL, including but not limited to de novo DLBCL; FL, Grades 1 to 3A; MCL; transformed lymphoma (tFL, RT) and FL Grade 3B; MZL and MALT.

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 2.

At least 1 measurable lesion per Lugano criteria.

Tumor tissue is available.

Disqualifiers

T-cell lymphoma

CLL or SL

Burkitt lymphoma and high-grade B-cell lymphoma

CNS involvement

Trial design

Design model

Sequential

Treatments tested in this trial

  • TORL-5-700

    Drug

    Part 1: Monotherapy Dose Escalation - TORL-5-700 Administered once every three weeks

  • TORL-5-700 at MTD/RP2D

    Drug

    Part 2: Monotherapy Expansion - TORL-5-700 at Maximum tolerated Dose (MTD)/Recommended Phase 2 Dose (RP2D) Administered once every three weeks

  • TORL-5-700 at MTD/RP2D in combination with another agent

    Drug

    Part 3: Combination Evaluation - TORL-5-700 at MTD/RP2D administered every three weeks in combination with another agent

Treatment groups

155 Participants
are divided into 3 treatment groups
Group A: Part 1: Monotherapy Dose EscalationExperimental treatment 1 intervention
Group B: Part 2: Monotherapy ExpansionExperimental treatment 1 intervention
Group C: Part 3: Combination EvaluationExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Evaluate the safety of TORL-5-700 as a monotherapy

Assessment of adverse events according to NCI-CTCAE Version 5.0

Time frame
though study completion, an average of 2.5 years
2

Assess the antitumor activity of TORL-5-700 as monotherapy

Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria

Time frame
though study completion, an average of 2.5 years
3

Evaluate the safety of TORL-5-700 in combination with other agents

Assessment of adverse events according to NCI-CTCAE Version 5.0

Time frame
though study completion, an average of 2.5 years
4

Determine the Maximum Tolerated Dose (MTD)

Determine the MTD by assessing Protocol defined Dose Limiting Toxicities (DLT)

Time frame
21 days from the start of treatment

Secondary outcomes

1

Maximum Serum Concentration of TORL-5-700 (Cmax)

Pk assessment

Time frame
though end of study treatment, an average of 5 months
2

Maximum Serum Concentration of TORL-5-700 (Cmax) in combination with other agents

Pk assessment

Time frame
though end of study treatment, an average of 5 months
3

Terminal Half-life (t1/2) of Serum TORL-5-700

Pk assessment

Time frame
though end of study treatment, an average of 5 months
4

Terminal Half-life (t1/2) of Serum TORL-5-700 in combination with other agents

Pk assessment

Time frame
though end of study treatment, an average of 5 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

TORL Biotherapeutics, LLC

Lead sponsor

Source ClinicalTrials.gov
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