Phase II Trial of Tunlametinib in Patients With NRAS Mutant Non-melanoma Refractory Solid Tumors

ConditionSolid Cancers
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Second Hospital

About this trial

This study is a single cohort, open label exploratory clinical trial aimed at observing and evaluating the efficacy and safety of Tunlametinib (HL-085) in the treatment of refractory solid tumors with advanced metastatic non melanoma. It is expected that the ORR of Tunlametinib (HL-085) treatment can reach 20%. According to the literature results, the experimental group rate is 0.2 and the target value rate is 0.02. If the bilateral alpha is 0.05 and the beta is 0.2, the sample size is calculated as 12 cases in the experimental group. Considering a 20% dropout rate, a total of 15 cases are required.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Have had other malignant tumors in the past 2 years (excluding tumors with low malignancy such as basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, papillary thyroid carcinoma, etc. that have undergone radical treatment) or have been diagnosed with melanoma;

Moderate or greater amounts of pleural effusion, pericardial effusion, and peritoneal effusion that cannot be controlled by researchers (including but not limited to those that require repeated drainage and have clinical symptoms);

Prior to initial administration of anti-tumor therapy: Within 4 weeks or 5 drug half lives (whichever is shorter) prior to administration, anti-tumor drugs (including cytotoxic therapy, targeted therapy, antibody therapy, immunotherapy, etc.) were administered; Received nitrosourea or mitomycin C treatment within 6 weeks prior to administration; Received palliative radiotherapy within 2 weeks prior to administration; Received other anti-tumor treatments such as radical radiotherapy and electric field therapy within 4 weeks before administration; Received traditional Chinese medicine treatment for anti-tumor indications within 2 weeks before administration;

Toxic reactions of previous anti-tumor treatments that have not yet improved to CTCAE ≤ 1 (excluding hair loss, skin toxicity, or other toxicity that researchers consider to be of no safety risk);

Trial design

Design model

Single group

Treatments tested in this trial

  • Tunlametinib

    Drug

    Do not chew, dissolve or open the capsule. If you miss a dose of medication, you can take the missed dose 8 hours before the next dose. If the time until the next medication is less than 8 hours, it is not recommended to take it again. Every 21 days for one cycle, subjects will use the investigational drug until the treatment termination criteria specified in the protocol are met. The recommended dosage for the first dose reduction is 9mg, twice daily. The recommended second dose reduction is 6mg, twice daily.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Tunlametinib (HL-085)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Objective Response Rate (ORR)

Objective Response Rate (ORR) assessed according to the evaluation criteria for the efficacy of solid tumors (RECIST v1.1).

Time frame
Up to approximately 24 months.

Secondary outcomes

1

Progression Free Survival(PFS)

The time from the beginning of the patient's treatment to the disease progression or death for any reason. Based on RECIST criteria v1.1.

Time frame
From treatment administration up to a maximum duration of 24 months.
2

Duration of Response(DOR)

Duration of Response, from the first time the evaluation results meet CR or PR criteria to the observation of PD or death.

Time frame
Time Frame: Through study completion, an expected average of 24 months
3

Disease Control Rate (DCR)

The proportion of subjects with complete response (CR) and partial response (PR) and stable disease (SD) in total subjects after the last subject participating in.

Time frame
From treatment administration up to a maximum duration of 18 months
4

Overall Survival(OS)

Overall Survival(OS)

Time frame
From treatment administration up to a maximum duration of 24 months.

Other outcomes

Sponsors and contacts

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