Health TrialsbyHealthPanel

A Study in Adults With Desmoid Tumors

ConditionDesmoid Tumor
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorElpiscience (Suzhou) Biopharma, Ltd.

About this trial

This is an open-label, multicenter, single-arm phase 2 clinical study designed to evaluate the efficacy, safety, tolerability, patient-reported outcomes (PROs), pharmacokinetics (PK), anti-drug antibody (ADA) and pharmacodynamics (PD) of ES014 in adult desmoid tumor patients.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

1) Histologically confirmed desmoid tumor.

2)Within 12 months prior to enrollment, meeting any of the following: Tumor target lesion growth ≥ 20% or appearance of new lesions;Desmoid tumor-related pain not adequately controlled by non-opioid medications.

3)Meeting any of the following conditions: Subjects with recurrence or disease progression after at least one line of treatment (including surgery, radiotherapy, or systemic therapy, etc.); Treatment-naive subjects who are deemed suitable for the study drug by the investigator.

4)Presence of at least one measurable lesion (according to RECIST v1.1).

Disqualifiers

1)Any prior therapy targeting CD39, CD73, adenosine A2A receptor, or TGF-β.

2)Receipt of any investigational agents or devices within 4 weeks prior to the first dose of study drug.

Anticancer therapy, including chemotherapy, tyrosine kinase inhibitors (TKIs), etc., within 28 days or 5 half-lives (whichever is shorter, but not less than 14 days) prior to the first dose of study drug.

For subjects who have received radiotherapy, a washout period of at least 2 weeks (limb radiation) or 4 weeks (chest, brain, or visceral organ radiation) is required before the start of study drug administration.

Trial design

Design model

Sequential

Treatments tested in this trial

  • ES014

    Drug

    ES014 is administered via intravenous infusion, 700mg once every 14 days.

  • ES014

    Drug

    ES014 is administered via intravenous infusion, 1400mg once every 14 days.

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Part1, Arm 1Experimental treatment 1 intervention
Group B: Part1, Arm 2Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective response rate (ORR) by IRC according to RECIST 1.1

Time frame
1-3 years

Secondary outcomes

1

Evaluate the safety and tolerability of ES014 in adult patients with desmoid tumors

The assessment is based on the changes in AE, SAE, as well as safety and laboratory evaluation parameters.

Time frame
1-3 years
2

The efficacy of ES014 in adult patients with desmoid tumors

Based on the IRC according to RECIST v1.1, the efficacy of ES014 in adult patients with hard desmoid tumors was assessed.

Time frame
1-3 years
3

Evaluate the PK of ES014

Evaluate based on the PK concentration of ES014

Time frame
1-3 years
4

Evaluate the immunogenicity of ES014

By observing the generation process of ADA in ES014 for evaluation

Time frame
1-3 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Elpiscience (Suzhou) Biopharma, Ltd.

Lead sponsor

Source ClinicalTrials.gov
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