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Safety, Tolerability, and Anti-cancer Activity of KAHR-102 (The Study Drug) for the Treatment of Lymphoma Patients

NCT02545361 · Status: WITHDRAWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL

Last updated 2018-08-16

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and to determine the Dose Limiting Toxicity (DLT) and the Maximal Tolerated Dose (MTD) of KAHR-102.

Conditions

Interventions

DRUG

KAHR-102

KAHR-102 is a dual signaling protein (DSP).KAHR-102 will be administrated subcutaneously. In Stage 1A, 3 KAHR-102 SC injections will continue to be given every 14 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles. In Stage 1B and Stage 2, subjects will be administered 3 KAHR-102 SC injections given every 7 days with an interval of 28 days after 1st cycle and 14 days after 2nd cycle and following cycles. Planned doses for stage 1: Cohort A: 2µg/kg Cohort B: 4 µg/kg Cohort C: 8 µg/kg Cohort D: 12 µg/kg Each cohort will only begin its first administration of KAHR-102 SC injection when the cohort preceding it will not meet criteria for a DLT (at least 7 days).

Sponsors & Collaborators

  • Kahr Medical

    lead INDUSTRY

Principal Investigators

  • Chava Sarfati, Pharm · Kahr Medical

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-30
Primary Completion
2020-04-30
Completion
2020-04-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02545361 on ClinicalTrials.gov