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Not yet recruitingNCT07893171Updated Oct 23, 2026

Study of CM529D1 in Participants With Advanced Solid Tumors

A Phase 1/2 interventional study of CM529D1 and CM529D1 in Advanced Solid Tumors, sponsored by Keymed Biosciences Co.Ltd. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2026-10-23.

Sponsored by Keymed Biosciences Co.Ltd · Phase 1/2, Interventional, and Treatment

Updated Oct 23, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
128
Allocation
Non-randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is interventional study to evaluate the safety and tolerability, pharmacokinetics, immunogenicity, and preliminary efficacy of CM529D1 in participants with advanced solid tumors.

02

Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

Keymed Biosciences Co.Ltd is the lead sponsor of 66 studies on the registry; 32 are open to participants now.

Browse Keymed Biosciences Co.Ltd studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Male or female ≥ 18 and ≤75 years of age.
  • Eastern Cooperative Oncology Group Performance Status score of 0 or 1.
  • Participants with histologically or cytologically confirmed advanced solid tumors.
  • At least one measurable lesion according to RECIST v1.1.
  • Expected survival time ≥ 3 months as judged by the Investigator.

Exclusion criteria

Exclusion Criteria:

  • Participants have received prior therapy with antibody-drug conjugates bearing a camptothecin or camptothecin derivative payload.
  • Participants who have received any chemotherapy, any anti-tumor therapy (including monoclonal antibodies, targeted therapy, radioimmunoconjugates, or Antibody-Drug Conjugates), or other investigational drugs within 28 days or 5 half-lives (whichever is shorter) prior to the first dose of investigational product.
  • Participants who have received major surgery within 28 days prior to the first dose.
  • Participants who have received radiotherapy within 21 days prior to the first dose.
  • Participants who have received systemic glucocorticoid therapy (more than 10 mg of prednisone or equivalent daily) or other forms of immunosuppressive therapy within 7 days prior to the first dose.
  • Participants with symptomatic central nervous system metastases.
  • History of any-grade interstitial lung disease (ILD) or known/suspected ILD.
  • History of other malignancies within 5 years prior to the first dose, excluding cured basal or squamous cell carcinoma of skin, carcinoma cervix in situ, or breast ductal carcinoma in situ.
  • Hypersensitivity to the investigational drug or its excipients.
  • Pregnant or lactating female patients.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
128 participants (estimated)

Study arms

  • Experimental
    Phase I dose escalation

    Biological: CM529D1

  • Experimental
    Phase I dose expansion

    Biological: CM529D1

  • Experimental
    Phase II

    Biological: CM529D1

Interventions

  • BiologicalCM529D1

    CM529D1 will be administered intravenously once every 3 weeks (Q3W) in 6 predetermined dose levels.

  • BiologicalCM529D1

    CM529D1 will be administered intravenously once every 3 weeks (Q3W) in one or more potential recommended phase 2 dose(RP2D).

  • BiologicalCM529D1

    CM529D1 will be administered intravenously once every 3 weeks (Q3W) in different types of solid tumor cohorts.

06

What researchers measure

Primary outcomes

  1. Dose Limiting Toxicity (DLT)-Phase I dose escalation

    DLT is defined as a toxicity occurring during the DLT observation period.

    Time frame: First cycle (21 days)

  2. Incidence of adverse events (AEs), serious adverse events (SAEs), and specific laboratory abnormalities-Phase I dose escalation

    An adverse event is defined as any unfavorable medical event that occurs in a subject after receiving the investigational drug, which will be graded according to Common Terminology Criteria for Adverse Events (CTCAE) v6.0 criteria.

    Time frame: Through study completion, an average of 2 years

  3. The Recommended Phase 2 Dose (RP2D)Phase I dose expansion

    RP2D is defined as the dose selected at the conclusion of Phase 1 dose- expansion, based on the integrated assessment of safety, tolerability, pharmacokinetics, and preliminary antitumor activity, and recommended for further evaluation in Phase 2 studies.

    Time frame: Through study completion, an average of 2 years

  4. Objective response rate (ORR)-Phase II

    ORR is defined as the proportions of subjects with a complete response (CR) and partial response (PR). ORR will be assessed by investigator according to Response Evaluation Criteria in Solid Tumors( RECIST) v1.1.

    Time frame: Through study completion, an average of 2 years

07

Study locations

1 site
  • Shanghai Chest Hospital
    Shanghai, China
08

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Nov 2026; primary completion for Dec 2029, 37 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2026
First posted
Oct 23, 2026
StartEst.
Nov 27, 2026
Primary completionEst.
Dec 31, 2029
CompletionEst.
Dec 31, 2030
Last update
Oct 23, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Registered
First appeared on the registry. No changes since
Oct 23, 2026
Show all 1 update
  1. Oct 23, 2026
    First appeared on the registry

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT07893171
Lead sponsor
Keymed Biosciences Co.Ltd
Responsible party
Sponsor
First posted
Oct 23, 2026
Start date
Nov 27, 2026 (estimated)
Primary completion
Dec 31, 2029 (estimated)
Completion
Dec 31, 2030 (estimated)
Last update
Oct 23, 2026

Study contacts

Qian Jia
Contact
clinicaltrial@keymedbio.com
028-88610620

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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