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Study of MHB036C in Participants With Advanced or Metastatic Solid Tumors

ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorMinghui Pharmaceutical Pty Ltd

About this trial

This study will evaluate the safety, pharmacokinetics, and anti-tumor efficacy of MHB036C in participants with advanced or metastatic solid tumors.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants voluntarily agree to participate in the study and sign the Informed Consent Form (ICF).

Participants aged 18 years or older (inclusive), without gender limitation.

Participants with ECOG performance score of 0 ~ 1.

Participants with expected survival time of more than 3 months.

Disqualifiers

Participants with 2 or more malignancies (except effectively treated non-melanoma skin cancer, cervical carcinoma in situ or other tumors, or malignancies considered cured) within 5 years prior to sign the Informed Consent Form.

Medication of nitrosourea or mitomycin C within 6 weeks prior to the first dose of MHB036C;

Medication of oral fluoropyrimidines or small molecule targeted agents within 5 half-lives of such drug before first dose of investigational product.

Medication of traditional Chinese medicine with anti-tumor indications within 2 weeks prior to the first dose of investigational product.

Trial design

Design model

Sequential

Treatments tested in this trial

  • MHB036C

    Drug

    MHB036C will be administered intravenously at a frequency of once every 3 weeks (Q3W).

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: Dose Escalation - All ParticipantsExperimental treatment 1 intervention
Group B: Dose Expansion - All ParticipantsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Number of participants with adverse events

Adverse events was assessed by investigator(s) according to NCI-CTCAE v5.0

Time frame
From the day of the first dose of MHB036C to 30 days after the day of the last dose of MHB036C
2

Number of participants with dose-limiting toxicities

Dose-limiting toxicities are defined as side effects of a drug or other treatment that are serious enough to prevent an increase in dose or level of that treatment

Time frame
21 days after the first dose of MHB036C

Secondary outcomes

1

Pharmacokinetics (PK) parameter: Maximum concentration (Cmax)

Categories: MHB036C, total antibody, free toxin MH30010008

Time frame
Within 5 cycles (each cycle is 21 days)
2

PK parameter: Time to maximum concentration (Tmax)

Categories: MHB036C, total antibody, free toxin MH30010008

Time frame
Within 5 cycles (each cycle is 21 days)
3

PK parameter: Area under the concentration-time curve (AUC)

Categories: MHB036C, total antibody, free toxin MH30010008

Time frame
Within 5 cycles (each cycle is 21 days)
4

PK parameter: Trough concentration (Ctrough)

Categories: MHB036C, total antibody, free toxin MH30010008

Time frame
Within 5 cycles (each cycle is 21 days)

Other outcomes

Sponsors and contacts

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

Minghui Pharmaceutical Pty Ltd

Lead sponsor

Source ClinicalTrials.gov

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