← Back to Search

Monoclonal Antibodies

Study of JK08 in Patients with Unresectable Locally Advanced or Metastatic Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by Salubris Biotherapeutics Inc

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up ay 1 of dosing through every 90 after the last dose.

Awards & highlights

No Placebo-Only Group

Summary

This is a Phase 1/2, open-label, multi-center, first-in-human, dose escalation and cohort expansion study evaluating multiple doses and schedules of subcutaneously administered JK08 in patients with unresectable locally, advanced or metastatic cancer.

Eligible Conditions

Squamous Cell Carcinoma
Cancer
Solid Tumors
Lung Cancer
Kidney Cell Carcinoma
Esophageal cancer
Pancreatic Adenocarcinoma
Liver Cancer
Thyroid Cancer
Bladder Cancer
Colorectal Cancer
Skin Cancer
Stomach Cancer
Breast Cancer
Renal Cell Carcinoma
Ovarian Cancer
Melanoma

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ ay 1 of dosing through every 90 after the last dose.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~ay 1 of dosing through every 90 after the last dose.

This trial's timeline: 3 weeks for screening, Varies for treatment, and ay 1 of dosing through every 90 after the last dose. for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Dose-Finding

Dose-limiting Toxicity (DLT)

Safety and Tolerability

Secondary study objectives

Disease Control Rate (DCR)

Objective Response Rate (ORR)

Overall Survival (OS)

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

4Treatment groups

Experimental Treatment

Group I: Dose Expansion Pembrolizumab Combination Cohort - Non-Small Cell Lung CancerExperimental Treatment2 Interventions

JK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Pembrolizumab will be given IV per standard institutional practice

Group II: Dose Expansion Pembrolizumab Combination Cohort - Colorectal CancerExperimental Treatment2 Interventions

Group III: Dose Expansion Lenvatinib Combination Cohort - Hepatocellular CancerExperimental Treatment2 Interventions

JK08 administered at the maximum-tolerated dose/recommended Phase 2 dose as a subcutaneous injection in patients with a mix of solid tumors. Lenvatinib will be given orally per standard institutional practice

Group IV: Dose EscalationExperimental Treatment1 Intervention

Escalating repeated doses of JK08 administered as a subcutaneous injection. A cycle of treatment is defined as 21 days, in which three doses of JK08 will be planned for administration.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Lenvatinib Pill

2018

Completed Phase 1

~30

Pembrolizumab

2017

Completed Phase 3

~3130