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Study of TYK-00540 Tablets in Patients With Advanced Solid Tumors

ConditionHR-positive, HER2-negative Advanced Breast Cancer
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTYK Medicines, Inc

About this trial

This study is to evaluate the safety, pharmacokinetics, and preliminary antitumor activity of TYK-00540 as monotherapy or combined with fulvestrant in advanced solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically or cytologically confirmed locally advanced/metastatic solid tumors with no standard treatment available, failure of/intolerance to standard treatment, or refusal of standard treatment.

Objective radiographic progression; OR

Persistent CA125 elevation (confirmed after 1 week) with clinical symptoms or signs of progression.

3 prior lines of chemotherapy for recurrent/metastatic disease, with ≤1 systemic therapy after platinum resistance.

Disqualifiers

Known hypersensitivity to any excipient of TYK-00540 or contraindication to fulvestrant (for Combination Dose-Selection and Combination Expansion Phases).

History of other malignancies, except:Cured basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, thyroid papillary carcinoma, ductal carcinoma in situ of the breast, or malignancies with disease-free survival >3 years.

Residual toxicity from prior therapy >Grade 1 (except alopecia or platinum-related neuropathy).

Central nervous system (CNS) disease:Primary CNS tumors, CNS metastases with prior local treatment failure, or newly diagnosed CNS metastases.Exception: Asymptomatic, stable CNS metastases (no steroids/CNS-specific treatment ≥14 days, radiologically confirmed stability at screening).

Trial design

Design model

Single group

Treatments tested in this trial

  • TYK-00540

    Drug

    Increased dose cohorts from low to MTD (5mg Cohort 1;10 mg Cohort 2; 20 mg Cohort 3; 30 mg Cohort 4;40 mg Cohort 5) decreased dose cohorts for the combination (TYK-00540 30 mg+Fulvestrant Cohort 1;TYK-00540 20mg +Fulvestrant)

Treatment groups

180 Participants
are divided into 1 treatment group
Group A: TYK-00540±FulvestrantExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose Limiting Toxicity (DLT)

Numbers of participants experiencing AEs which are defined as DLTs classfied by CTCAE

Time frame
Within 31 days of the first dose
2

Recommended dose for combination-agent escalation and single-agent expansion (RDE)

To determine the recommended dose for combination-agent escalation and single-agent expansion agent expansion.

Time frame
1 year
3

Adverse events (AEs)

Number of participants with treatment-related adverse events as assessed by CTCAE v5.0.

Time frame
From Baseline up to 28 days after the end of the treatment
4

Objective response rate (ORR)

ORR is defined as the proportion of patients with a best overall response of complete response (CR) or partial response (PR) assessment in accordance to Response Evaluation Criteria in Solid Tumors (RECIST 1.1)

Time frame
At least 24 weeks

Secondary outcomes

1

The time to the peak concentration (Tmax)

Tmax is defined as the time of maximum concentration of the drug in blood observed after a drug dose administration.

Time frame
0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
2

Maximum plasma concentration (Cmax)

Cmax is the maximum (or peak) plasma concentration that the drug achieves in blood after the drug has been administered.

Time frame
0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
3

Minimum plasma concentration (Cmin)

Cmin is the minimum plasma concentration that the drug achieves in blood after the drug has been administered.

Time frame
0 hours (h) (within 30 min before dosing), 0.25 h, 0.5 h , 1 h , 2 h , 3 h, 4 h, 8 h , 12 h, 24 h after dosing
4

Disease Control Rate (DCR)

DCR is defined as the proportion of patients with a best overall response of complete response (CR) , partial response (PR) or Stable disease (SD) ≥6 weeks during the study treatment

Time frame
At least 24 weeks

Other outcomes

Sponsors and contacts

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

TYK Medicines, Inc

Lead sponsor

Source ClinicalTrials.gov
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