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

Condition(s) studied

Investigational drug(s) / intervention(s)

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

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

Study summary

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

Primary outcome measure(s)

• Evaluate the safety of TORL-5-700 as a monotherapy — though study completion, an average of 2.5 years
  Assessment of adverse events according to NCI-CTCAE Version 5.0
• Assess the antitumor activity of TORL-5-700 as monotherapy — though study completion, an average of 2.5 years
  Assess the antitumor activity of TORL-5-700 using Cheson (2014) disease grading criteria
• Evaluate the safety of TORL-5-700 in combination with other agents — though study completion, an average of 2.5 years
  Assessment of adverse events according to NCI-CTCAE Version 5.0
• Determine the Maximum Tolerated Dose (MTD) — 21 days from the start of treatment
  Determine the MTD by assessing Protocol defined Dose Limiting Toxicities (DLT)
• Determine the Recommended Phase 2 Dose (RP2D) — 21 days from the start of treatment
  Determine the RP2D by assessing Protocol defined Dose Limiting Toxicities

Trial sites (9)

More TORL Biotherapeutics, LLC trials in the USA