ClinicalTrials.gg
Status unknownNCT05942378Updated Jul 12, 2023

A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors

A Phase 1 interventional study of HRXG-K-1939 and Adebrelimab in Advanced Solid Tumors, sponsored by Fudan University. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-07-12.

Sponsored by Fudan University · Phase 1, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jul 2023), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 1
Study type
Interventional
Enrollment
30
Allocation
Not applicable
Ages
18 Years to 75 Years
Sex
All
01

Study summary

This is a Phase 1, open-label study evaluating the efficacy and safety of HRXG-K-1939 in combination with Adebrelimab (anti-programmed death-ligand 1 [anti-PD-L1] antibody) in patients with advanced solid tumors. HRXG-K-1939 will be administered to patients in a dose escalation regimen to determine a recommended dose for expansion.

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Conditions studied

  • Advanced Solid Tumors
03

In context

Lead sponsor

Fudan University is the lead sponsor of 1,308 studies on the registry; 637 are open to participants now.

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

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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

  1. Voluntarily signed the informed consent form and complied with protocols requirements;
  2. Patients with advanced solid tumors that are suitable for immunotherapy;
  3. ECOG Performance Status of 0 or 1;
  4. Life expectancy ≥ 12 weeks;
  5. At least one measurable disease per RECIST v1.1;
  6. Tumor specimen availability;
  7. Adequate marrow and organ function;
  8. Have resolution of toxic effects from prior therapy to Grade 1 or less (except for Grade ≤2 alopecia or neuropathy) per CTCAE v5.0;
  9. Patients with fertility are willing to use an adequate method of contraception.

Exclusion criteria

Exclusion Criteria:

  1. Previously detected positive driver genes (EGFR, ALK, ROS1, etc.);
  2. Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled);
  3. Uncontrolled pleural effusion, pericardial effusion, or ascites;
  4. Major surgical procedure within 28 days prior to initiation of study treatment or anticipation of need for a major surgical procedure during the course of the study;
  5. Prior anti-cancer therapy (e.g., chemotherapy, radiotherapy, hormonal therapy, targeted therapy, immunotherapy, any other investigational or immunomodulatory drugs) within 21 days prior to initiation of study treatment;
  6. Live-attenuated vaccination within 28 days prior to initiation of study treatment through 60 days after the end of study;
  7. Systemic steroid therapy or other form of immunosuppressive therapy within 14 days prior to initiation of study treatment;
  8. Any history of an immune-mediated Grade 4 adverse event or Grade 3 adverse event that resulted in permanent discontinuation;
  9. Active or history of autoimmune disease;
  10. Active tuberculosis or infection requiring treatment;
  11. History of interstitial lung disease;
  12. Allergic to research drug ingredients;
  13. Prior malignancy within 5 years prior to study entry;
  14. Solid organ or allogeneic bone marrow transplant;
  15. HIV positive, HCV positive, HBV DNA copies ≥ 10\^3;
  16. Significant cardiovascular disease;
  17. Other situations that are not suitable for inclusion in this study judged by investigator
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    HRXG-K-1939 Combined with Adebrelimab

    Dose Escalation: HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab

    Drug: HRXG-K-1939 · Drug: Adebrelimab

Interventions

  • DrugHRXG-K-1939

    HRXG-K-1939

    Also known as: HRXG-K-1939 is a mRNA cancer vaccines

  • Adebrelimab is a programmed death-ligand 1 antibody

06

What researchers measure

Primary outcomes

  1. Dose Escalation Phase:RP2D

    Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939

    Time frame: 9 months

  2. • Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood

    • Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood

    Time frame: Baseline through 12 months after last HRXG-K-1939 dose

Secondary outcomes

  1. Objective Response Rate(ORR)

    The proportion of patients who have a CR or PR, as determined by the Investigator at local site per RECIST 1.1.

    Time frame: 12 months

  2. Disease Control Rate (DCR)

    The proportion of patients who have a CR or PR or SD, as determined by the Investigator at local site per RECIST 1.1.

    Time frame: 12 months

  3. Duration of Response (DoR)

    Time from the date of first documented response until the date of documented progression or death in the absence of disease progression.

    Time frame: 12 months

  4. Progression Free Survival (PFS)

    Time to progression as assessed by the Investigator at local site per RECIST 1.1, or death due to any cause.

    Time frame: 12 months

  5. Overall Survival (OS)

    Time to death due to any cause

    Time frame: 24 months

  6. Adverse Events(AEs)

    Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0

    Time frame: From consent to 90 days after the final dose of study drug

  7. Biomarker analysis

    Serum cytokines (IL-10, IL-6, IL-2, TNF- α, IFN- γ ) Changes from baseline condition

    Time frame: Baseline through 12 months after last HRXG-K-1939 dose

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Study locations

1 site
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References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

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Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Jul 2023; primary completion for Sep 2025, 26 months later.

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

Registered
Jun 21, 2023
First posted
Jul 12, 2023
StartEst.
Jul 1, 2023
Primary completionEst.
Sep 1, 2025
CompletionEst.
Dec 1, 2025
Last update
Jul 12, 2023
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.
No changes since tracking began. The registry record was last updated on Jul 12, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05942378
Lead sponsor
Fudan University
Responsible party
Jian Zhang,MD (MD, Ph.D, Fudan University) — Principal investigator
First posted
Jul 12, 2023
Start date
Jul 1, 2023 (estimated)
Primary completion
Sep 1, 2025 (estimated)
Completion
Dec 1, 2025 (estimated)
Last update
Jul 12, 2023

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Adebrelimab

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