Advanced Solid TumorsPhase 1NCT05942378
A Study of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
A Phase 1 study testing HRXG-K-1939 and Adebrelimab in people with Advanced Solid Tumors, run by Fudan University at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced Solid Tumors
- What is being tested?
- HRXG-K-1939 and Adebrelimab
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 1 Dec 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily signed the informed consent form and complied with protocols requirements;
- Patients with advanced solid tumors that are suitable for immunotherapy;
- ECOG Performance Status of 0 or 1;
- Life expectancy ≥ 12 weeks;
- At least one measurable disease per RECIST v1.1;
- Tumor specimen availability;
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- Adequate marrow and organ function;
- Have resolution of toxic effects from prior therapy to Grade 1 or less (except for Grade ≤2 alopecia or neuropathy) per CTCAE v5.0;
- Patients with fertility are willing to use an adequate method of contraception.
Who cannot join
- Previously detected positive driver genes (EGFR, ALK, ROS1, etc.);
- Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled);
- Uncontrolled pleural effusion, pericardial effusion, or ascites;
- 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;
- 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;
- Live-attenuated vaccination within 28 days prior to initiation of study treatment through 60 days after the end of study;
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- Systemic steroid therapy or other form of immunosuppressive therapy within 14 days prior to initiation of study treatment;
- Any history of an immune-mediated Grade 4 adverse event or Grade 3 adverse event that resulted in permanent discontinuation;
- Active or history of autoimmune disease;
- Active tuberculosis or infection requiring treatment;
- History of interstitial lung disease;
- Allergic to research drug ingredients;
- Prior malignancy within 5 years prior to study entry;
- Solid organ or allogeneic bone marrow transplant;
- HIV positive, HCV positive, HBV DNA copies ≥ 10^3;
- Significant cardiovascular disease;
- Other situations that are not suitable for inclusion in this study judged by investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, MD, 86-021-64175590 ext. 73546, Syner2000@163.com
Yanchun Meng, MD, ycmclinicaltrials@126.com
About this study
Official title: A Phase 1 Study to Evaluate the Efficacy and Safety of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
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.
- Conditions
- Advanced Solid Tumors
- Being tested
- HRXG-K-1939, Adebrelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HRXG-K-1939Drug
Also called HRXG-K-1939 is a mRNA cancer vaccines
HRXG-K-1939
AdebrelimabDrug
Adebrelimab is a programmed death-ligand 1 antibody
| Study group | Role | What they receive |
|---|---|---|
| HRXG-K-1939 Combined with Adebrelimab | Experimental | Dose Escalation:
HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab Receives: Drug: HRXG-K-1939; Drug: Adebrelimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Escalation Phase:RP2D
Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939
Measured: 9 months
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
- Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
Measured: Baseline through 12 months after last HRXG-K-1939 dose
Secondary outcomes (7)
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
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.
Measured: 12 months
Overall Survival (OS)
Time to death due to any cause
Measured: 24 months
Adverse Events(AEs)
Occurrence of Adverse Events(AEs) graded according to CTCAE v5.0
Measured: From consent to 90 days after the final dose of study drug
Biomarker analysis
Serum cytokines (IL-10, IL-6, IL-2, TNF- α, IFN- γ ) Changes from baseline condition
Measured: Baseline through 12 months after last HRXG-K-1939 dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2023
- Study start1 Jul 2023 (estimated)
- Primary completion1 Sep 2025 (estimated)
- Study completion1 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Solid TumorsStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05942378
- Sponsor's protocol ID
- IIT-HRXG-K-193
- Status last verified
- Jul 2023
- First submitted
- 21 Jun 2023
- Last updated
- 12 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Efficacy and Safety of HRXG-K-1939 and Adebrelimab in Patients With Advanced Solid Tumors
- ClinicalTrials.gov ID
- NCT05942378
- Acronym / sponsor ID
- IIT-HRXG-K-193
- Conditions
- Advanced Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Study start
- 1 Jul 2023 (estimated)
- Primary completion
- 1 Sep 2025 (estimated)
- Study completion
- 1 Dec 2025 (estimated)
- First posted
- 12 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HRXG-K-1939 Combined with Adebrelimab | Experimental | Drug: HRXG-K-1939, Drug: AdebrelimabDose Escalation: HRXG-K-1939 at escalated dosages with Adebrelimab Experimental: Dose Expansion HRXG-K-1939 at recommended dose with Adebrelimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Voluntarily signed the informed consent form and complied with protocols requirements;
- Patients with advanced solid tumors that are suitable for immunotherapy;
- ECOG Performance Status of 0 or 1;
- Life expectancy ≥ 12 weeks;
- At least one measurable disease per RECIST v1.1;
Key exclusion criteria (17 listed)
- Previously detected positive driver genes (EGFR, ALK, ROS1, etc.);
- Have leptomeningeal, or actively progressing CNS metastases (patients with stable brain metastases can be enrolled);
- Uncontrolled pleural effusion, pericardial effusion, or ascites;
- 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;
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HRXG-K-1939Also: HRXG-K-1939 is a mRNA cancer vaccinesHRXG-K-1939 | Drug | HRXG-K-1939 Combined with Adebrelimab |
| AdebrelimabAdebrelimab is a programmed death-ligand 1 antibody | Drug | HRXG-K-1939 Combined with Adebrelimab |
Primary outcome
Dose Escalation Phase:RP2D
Time frame: 9 months
Dose Escalation Phase: Recommended Phase 2 Dose (RP2D) of HRXG-K-1939
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
Time frame: Baseline through 12 months after last HRXG-K-1939 dose
• Dose Expansion Phase: Antigen-Specific T-cell Responses in Peripheral Blood
7 secondary outcomes
Objective Response Rate(ORR)
Time frame: 12 months
Disease Control Rate (DCR)
Time frame: 12 months
Duration of Response (DoR)
Time frame: 12 months
Progression Free Survival (PFS)
Time frame: 12 months
Overall Survival (OS)
Time frame: 24 months
Adverse Events(AEs)
Time frame: From consent to 90 days after the final dose of study drug
Biomarker analysis
Time frame: Baseline through 12 months after last HRXG-K-1939 dose
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing HRXG-K-1939 and Adebrelimab in people with Advanced Solid Tumors, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Escalation Phase:RP2D (time frame: 9 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2023.