Study of Alkotinib in Patients With Advanced Non Small Cell Lung Cancer (NSCLC)

Zelgen Biopharmaceuticals

Status and phase: Completed; Phase 1

Conditions: Non-small Cell Lung Cancer

Treatments: Drug: Alkotinib

Study type: Interventional

Funder types: Industry

Identifiers

NCT03607188

ZGALK001

Details and patient eligibility

About

To explore the DLT of ZG0418 for Patients with Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib, and to determine the MTD or the R2PD.

Full description

The study is a randomized, double-blind phase 1 trial including 2 sequential parts: single ascending dose(SAD) part,multiple ascending dose(MAD) part. SAD and MAD are dose-escalated tolerant study designing. The aims of the study as below:

1. Evaluating the safety and tolerance of ZG0418 in ALK+ NSCLC.
2. Evaluating the fasting pharmacokinetic parameters of ZG0418 in ALK+ NSCLCJaktinib.
3. Evaluating the postprandial pharmacokinetic parameters of ZG0418 in ALK+ NSCLC.
4. Analysis the metabolites of ZG0418

Enrollment: 17 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Advanced ALK+ or ROS1+ NSCLC And Previously Treated with Chemotherapy or Crizotinib

2. Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) score of 0 to 2.

3. Life expectancy of at least 12 weeks.

4. Ability to swallow and retain oral medication.

5. Adequate organ system function, defined as follows:

   1. Absolute neutrophil count (ANC) ≥1.5 x 10^9/L

   2. Platelets ≥75 x 10^9/L

   3. Hemoglobin ≥9 g/dL (≥90 g/L) Note that transfusions are allowed to meet the required hemoglobin level

   4. Total bilirubin ≤1.5 times the upper limit of normal (ULN)

   5. Alanine aminotransferase (ALT) and aspartate aminotransferase (AST)

      ≤2.5 x ULN if no liver involvement or ≤5 x ULN with liver involvement.

   6. Creatinine 1.5 x ULN.

6. Brain metastases allowed if asymptomatic at study baseline.

7. Patients must have measurable disease per RECIST v. 1.1.

Exclusion criteria

1. chemotherapy, radiation therapy, immunotherapy within 4 weeks.
2. Presence of active gastrointestinal (GI) disease or other condition that will interfere significantly with the absorption, distribution, metabolism, or excretion of study medications.
3. uncontrolled mass of pleural effusion, pericardial effusion, and peritoneal effusion.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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17 participants in 5 patient groups

ZG0418 200mg QD

Experimental group

Description:

ZG0418 200mg/day,oral

Treatment:

Drug: Alkotinib

ZG0418 300mg QD

Experimental group

Description:

ZG0418 300mg/day,oral

Treatment:

Drug: Alkotinib

ZG0418 400mg QD

Experimental group

Description:

ZG0418 400mg/day,oral

Treatment:

Drug: Alkotinib

ZG0418 500mg QD

Experimental group

Description:

ZG0418 500mg/day,oral

Treatment:

Drug: Alkotinib

ZG0418 600mg QD

Experimental group

Description:

ZG0418 600mg/day,oral

Treatment:

Drug: Alkotinib