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

NCT02545361 | Withdrawn Phase 1 DMC

• 1 other identifier: KAHR002
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief 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

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Evaluate incidence of adverse events

  Safety, as determined by frequency, nature, and severity of adverse events; and the profile of dose limiting toxicities.

  Up to 9 months

Secondary Outcomes (4)

• Blood samplings for KAHR-102 levels

  Stage 1A: Pre-dose, days 1, 2, 28, 29 (Injections 1 and 3). Stages 1B and 2: Pre-dose, days 1, 2 ,14 ,15 (Injections 1 and 3). Repeated on Day 4, 7, 32 and 35.

• Blood sampling for Anti-Drug Antibodies (ADAs)

  Stage 1A: Pre-dose day 1, 14, 28 in all cycles, day 49; Stages 1B and 2: Pre-dose day 1 and 28 in all cycles, day 35.

• Tumors measurements

  Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.

• Optional "LUGANO" classification response

  Stage 1A: Pre-dose, day 49; Stages 1B and 2: Pre-dose, day 35 and every 10 weeks on average.

Study Arms (1)

KAHR002

EXPERIMENTAL

premedication (20mg Dexamethasone (IV), 10mg Loratadine (P.O), and 1gr Paracetamol (P.O), 1 hour before treatment) with 2µg/kg KAHR-102 subcutaneous (SC) injection

Drug: KAHR-102

Interventions

KAHR-102 DRUG

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).

KAHR002

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects diagnosed with recurrent malignant lymphoma, which express B7 and FasR and have either failed to respond to standard therapy, relapsed and for whom no standard therapy is available.
• Measurable disease as measured by "Lugano" Classification.
• A measurable node must have a longest diameter (LDi) greater than 1.5 cm. Measurable extranodal disease (eg, hepatic nodules) may be included in the six representative, measured lesions. A measurable extranodal lesion should have an LDi greater than 1.0 cm
• Biopsy of tumor stains positive to cluster of differentiation 95 (CD95) and to Cluster of Differentiation 80 (CD80) or Cluster of Differentiation 86 (CD86) or both within the last 6 months.
• If greater than 6 months , a fine-needle aspiration (FNA) should be performed
• Men and Women age \> 18.
• Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 3.
• Estimated life expectancy of at least 2 months.
• Adequate liver function (serum bilirubin ≤2.0 mg/100 ml; alanine aminotransferase, aspartate aminotransferase ≤2× ULN).
• Adequate renal function (serum creatinine ≤1.5 mg/100 ml or creatinine clearance ≥30 ml/min/1.73m2 as measured by Cockcroft -Gault / CKD (Chronic Kidney Disease)/EPI (Epidemiology Collaboration) formulas.
• Platelet count ≥ 50,000 and an absolute neutrophil count (ANC) ≥ 1500 /mm3.
• Women of child bearing potential practicing an acceptable method of birth control.
• Understanding of study procedures and willingness to comply for the entire length of the study and to give written informed consent.

You may not qualify if:

• Other standard anti-neoplastic therapies are available.
• Known Central Nervous System (CNS) lymphoma.
• Chronic lymphocytic leukemia and autoimmunity leukemia.
• Known hypersensitivity to the study drug or to any of its components.
• Chronic heat failure (CHF) New-York heart association (NYHA) = Class IV.
• Known Chronic Obstructive Pulmonary Disease (COPD) \> Stage 3 (Forced Expiratory Volume -(FEV1)\<50%, FEV1/Forced Vital Capacity (FVC)\<70%).
• Chronic kidney disease (CKD) \>Stage 4 (subjects with known Filtration rate (FR)\<30 milliliter (mL)/min/1.73m2).
• Cirrhosis (Child-Pugh Class C score).
• Known hypersensitivity to drug components.
• Prior chemotherapy within 3 weeks, nitrosureas within 6 weeks, therapeutic anticancer antibodies within 3 weeks, radio or toxin immunoconjugates within 10 weeks, radiation therapy within 3 weeks, or major surgery within 28 days of first dose of the study drug.
• American Society for Cytotechnology (ASCT) and prior allogeneic stem cell transplantation (SCT)\< 12 weeks prior to first dose of the study drug.
• Myelosuppressive treatment within 2-3 weeks of entering this study. Prednisone allowed.
• Any other severe concurrent disease which in the judgment of the investigator would make the subject inappropriate for entry into this study.
• Positive test for acquired immune deficiency syndrome (AIDS).
• Any positive test for hepatitis B or hepatitis C virus (HBV or HCV) indicating acute or chronic infection (HBsAg, HBcAb total and anti-HCV Abs).

Sponsors & Collaborators

• Kahr Medical: lead

MeSH Terms

Conditions

Lymphoma

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Chava Sarfati, Pharm

  Kahr Medical

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2015
• First Posted: September 10, 2015
• Study Start: April 1, 2018
• Primary Completion: April 1, 2020
• Study Completion: April 1, 2020
• Last Updated: August 16, 2018

Record last verified: 2018-08