Health TrialsbyHealthPanel

Study of SNH-118110 in Advanced Solid Tumors

ConditionSolid Tumors
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorScinnoHub Pharmaceutical Co., Ltd.

About this trial

This is a multicenter, open-label, Phase I clinical study to evaluate the safety, tolerability, pharmacokinetics, and efficacy of SNH-118110 administered orally. The study consists of a dose-escalation phase and a dose-expansion phase.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Ability to understand and voluntarily sign an informed consent form (ICF) prior to any study related procedures.

Age ≥ 18 years at the time of signing the ICF.

At least one measurable target lesion according to RECIST version 1.1.

Documentation of a RET fusion or other activating RET gene alteration (based on a local or central laboratory report).

Disqualifiers

Presence of other known oncogenic driver mutations.

Prior anti-tumor therapy within specified washout periods prior to first dose (e.g., small molecules, biologics, radiotherapy, major surgery), or failure to recover from clinically significant toxicities.

Conditions affecting oral drug absorption or gastrointestinal function.

History of severe allergic reactions to similar agents.

Trial design

Design model

Single group

Treatments tested in this trial

  • SNH-118110 Soft Capsules

    Drug

    Participants will continue treatment until progression of disease or the end of the study.

Treatment groups

240 Participants
are divided into 1 treatment group
Group A: SNH-118110Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Safety evaluation

Incidence and severity of adverse events (AEs) and serious adverse events (SAEs).

Time frame
Up to approximately 2 years
2

Maximum tolerated dose (MTD) or maximum administered dose (MAD)

Determination of the MTD or MAD of oral SNH-118110 by the number of participants who experience a dose limiting toxicity (DLT)

Time frame
Cycle 1 (up to 21 days)

Secondary outcomes

1

The maximum concentration (Cmax)

Cmax of SNH-118110

Time frame
Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
2

Time of the maximum concentration (Tmax)

Tmax of SNH-118110

Time frame
Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
3

Area under the concentration-time curve from time zero (pre-dose) to last time of quantifiable concentration (AUC0-t)

AUC0-t of SNH-118110

Time frame
Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)
4

Elimination half-life (t1/2)

T1/2 of SNH-118110

Time frame
Cycle 1 day 1 through cycle 2 day 1 (cycle= 21 days)

Other outcomes

Sponsors and contacts

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

ScinnoHub Pharmaceutical Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: