Recent Updates
Recently added Catalysts

CDX-1140

Phase 1

Melanoma | Small molecule | Oncology |Celldex Therapeutics, Inc.|Last Updated: Mar 28, 2024

Target and mechanism

Molecular targetCD40
Target classAgonist
ModalitySmall molecule

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

CONTROLLED
Total Trials1
Total Enrollment132

FDA Designations

No designations recorded

Clinical trial landscape

CDX-1140 · 1 trial · 26 indications

Phase 1 1
NCT03329950A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced MalignanciesMelanoma
COMPLETED132 Analytics
PHASE1COMPLETED
A Study of CDX-1140 (CD40) as Monotherapy or in Combination in Patients With Advanced Malignancies
MelanomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Safety and Tolerability of CDX-1140 as assessed by CTCAE v5.0
From first dose through 30 days after last dose

The rates of drug-related adverse events will be summarized and maximum tolerated dose will be determined.

Secondary Endpoints

Objective Response Rate
Every 8-12 weeks, starting with first dose until disease progression, assessed up to approximately 1-3 years.
Clinical benefit rate
Every 8-12 weeks, starting with first dose until disease progression, assessed up to approximately 1-3 years
Duration of Response
First occurrence of a documented objective response to disease progression or death (up to approximately 1-3 years)
Unlock Study Endpoints

Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CDX-1140EXPERIMENTALPart 1: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance, or two years of treatment.
CDX-1140 and CDX-301EXPERIMENTALPart 2: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, intolerance or two years of treatment. A fixed dose of CDX-301 is injected once a day for five days before cycles 1 and 2 of CDX-1140.
CDX-1140 and pembrolizumabEXPERIMENTALPart 3: Eligible patients will receive CDX-1140, based on cohort assigned, in 3 week cycles until progression, or intolerance, or two years of treatment. A fixed dose of pembrolizumab will also be given in 3 week cycles.
CDX-1140 and chemotherapyEXPERIMENTALPart 4: Eligible patients will receive CDX-1140, based on cohort assigned, in 4 week cycles until progression, or intolerance, or two years of treatment. Chemotherapy will also be given according to standard of care.

Interventions

NameTypeDescription
CDX-1140DRUGCDX-1140 will be administered every 4 weeks in Parts 1, 2 and 4, and every 3 weeks in Part 3.
CDX-301DRUGCDX-301 will be injected once a day for five days before Cycles 1 and 2.
pembrolizumabDRUGpembrolizumab will be administered every 3 weeks.
ChemotherapyDRUGGemcitabine and Nab-paclitaxel will be administered on Day 1, Day 8 and Day 15 of each 4 week Cycle.
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites11

Key Inclusion Criteria: 1. Recurrent, locally advanced or metastatic melanoma (including mucosal and/or ocular), bladder/urothelial, non-small cell lung cancer, pancreatic adenocarcinoma, breast, colorectal, gastric, esophageal, renal cell, hepatic, ovarian fallopian or primary peritoneal carcinoma...

Countries:United States
Unlock Eligibility Criteria

Frequently asked questions about CDX-1140

What is CDX-1140 used for in melanoma?

CDX-1140 is an investigational small molecule being studied for the treatment of melanoma. It was evaluated in a Phase 1 clinical trial as a monotherapy or in combination for patients with advanced malignancies, including melanoma. The drug is being developed by Celldex Therapeutics, Inc. and is not yet approved.

What does CDX-1140 target?

CDX-1140 targets CD40, as indicated by the clinical trial title. CD40 is a protein involved in immune system regulation. By targeting CD40, the drug aims to modulate immune responses in the treatment of advanced malignancies, including melanoma.

Who makes CDX-1140?

CDX-1140 is being developed by Celldex Therapeutics, Inc., a biopharmaceutical company. The company's stock ticker is CLDX. The drug is currently in clinical development for oncology indications.

What phase is CDX-1140 in?

CDX-1140 is in Phase 1 clinical development. It has completed a Phase 1 trial, and the drug remains investigational. It is not FDA approved, and its safety and efficacy are still being evaluated in clinical studies.

What clinical trials is CDX-1140 in?

CDX-1140 has been studied in one clinical trial with the identifier NCT03329950. This Phase 1 study evaluated CDX-1140 as monotherapy or in combination in patients with advanced malignancies, including melanoma. The trial was completed and enrolled 132 participants in the United States.

Is CDX-1140 the same as CD40?

CDX-1140 is not the same as CD40; rather, it targets CD40. The clinical trial title refers to CDX-1140 as a CD40-targeting agent. CD40 is the molecular target of the drug, not an alternative name for CDX-1140 itself.