A Trial of ZL-1201 in Subjects With Advanced Cancer

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-05-11

Study Completion Date

2023-01-19

Brief Summary

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First in Human, Phase I Trial of ZL-1201 in Subjects with Advanced Cancer

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Detailed Description

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This is a first-in-human, dose escalation trial of ZL-1201. The major aims of the study are to define the safety profile of this new drug, and to determine a recommended dose and schedule for potential additional trials.

Conditions

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Advanced Cancer

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Single arm, ZL-1201

Group Type EXPERIMENTAL

ZL-1201

Intervention Type DRUG

Part 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.

Interventions

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ZL-1201

Part 1 \& 2: Escalating dose of ZL-1201, Part 3: three dose levels determined from Part 1 and Part 2.

Intervention Type DRUG

Other Intervention Names

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Monotherapy

Eligibility Criteria

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Inclusion Criteria

* Histologically/cytologically confirmed, locally advanced unresectable or metastatic solid tumors and lymphomas that are refractory or intolerant to standard of care therapy, or for which no standard therapy exists.
* Adequate hematologic status
* Adequate coagulation function
* Adequate hepatic function
* Adequate renal function

Exclusion Criteria

* Known active brain metastases
* Red blood cells transfusion dependence
* Known cardiopulmonary disease
* Pregnant or breast-feeding females
* Any other serious underlying medical

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No