Breast Cancer, Colorectal CancerEarly Phase 1FAST-CRNCT06756295
A Phase I/ II Study of Fragmented Autoantigen Stimulated T-cell-immunotherapy Combined with Radiotherapy (FAST-CR)
A Early Phase 1 study testing individualized tumor FAST vaccine combination (including adjuvant) in people with Breast Cancer, Colorectal Cancer and Melanoma, run by Fengming Kong.
Trial summary
Evaluation and exploration of the phase I/II clinical safety and efficacy of personalized FAST(Radiation fueled antigens stimulated T-cell immunotherapy )cancer vaccine combined with radiotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Melanoma, Lung Cancer
- What is being tested?
- individualized tumor FAST vaccine combination (including adjuvant)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 154 participants
- Where
- No sites listed yet
- Study dates
- 25 Mar 2025to 1 Mar 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily agree to participate in this study. Age: 18-80 years, regardless of gender. Pathological and imaging diagnosis of advanced or recurrent malignant tumors. The patient must have previously received systemic standard treatment that has failed or led to disease progression, with no effective first-line treatment options available for advanced tumors (effective treatment options refer to the latest clinical guidelines published by the "Chinese Society of Clinical Oncology"). Alternatively, the patient may have undergone standard surgical treatment for tumor relapse prevention.
- At least one measurable lesion on imaging (excluding patients who have undergone surgical treatment).
- Expected survival ≥ 6 months. ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1. No infectious diseases: HIV antibody negative. Normal hematological function: White blood cells ≥ 3000 cells/µL, hemoglobin ≥ 9 g/dL, platelets ≥ 75,000 cells/µL, absolute neutrophil count > 1000 cells/mm³.
- Normal renal function: Serum creatinine (Cr) ≤ ULN × 1.5. Normal liver function: Serum ALT/AST levels less than three times the upper limit of normal.
- The patient must be willing to sign an informed consent form and able to comply with the treatment plan.
- The patient must undergo tumor resection or biopsy (for vaccine preparation) and peripheral blood collection (for efficacy and prognosis evaluation).
Who cannot join
- Patients who do not have enough tumor resected or puncture tissue for vaccine production.
- Patients who have failed third-line therapy, and whose tumor location or type is not suitable for radiotherapy (as evaluated by the expert group).
- Patients whose tumor tissue preparation for the vaccine does not meet the efficacy assessment criteria before enrollment (individualized FAST vaccine Elispot test, see Appendix 4 for specific testing protocol).
- Patients with a history of bone marrow or stem cell transplantation. Patients currently participating in other therapeutic clinical trials; Traditional Chinese medicine clinical trials.
- Patients with active bacterial or fungal infections as per NCI-CTC (National Cancer Institute Common Terminology Criteria for Adverse Events) CTCAE 5.0.
- Patients infected with HIV (Human Immunodeficiency Virus), HCV (Hepatitis C Virus), HBV (Hepatitis B Virus), severe asthma, autoimmune diseases, immunodeficiency, or those undergoing immunosuppressive therapy.
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- Patients with herpesvirus infection (except those whose lesions have scabbed for more than 4 weeks).
- Patients with respiratory viral infections (except those who have been cured for more than 4 weeks).
- Patients with severe coronary artery or cerebrovascular diseases, or other diseases that the investigator considers should be excluded.
- Patients with clinical, psychological, or social factors that affect their ability to provide informed consent for the study.
- Patients with a history of autoimmune diseases, such as but not limited to inflammatory bowel disease, systemic lupus erythematosus, ankylosing spondylitis, scleroderma, or multiple sclerosis. Patients with autoimmune-related thyroid diseases and vitiligo are allowed.
- Patients with severe chronic or acute comorbidities, such as heart disease (NYHA Class III or IV), liver disease, or other diseases that the principal investigator considers to pose unnecessary high risk in relation to the study drug treatment.
- Patients who have a second malignant tumor at the same time (or within the past 5 years), except for melanoma skin cancer, cervical carcinoma in situ, controlled superficial bladder cancer, or other treated carcinoma in situ.
- Patients with active acute or chronic infections, including urinary tract infections, HIV (as confirmed by ELISA and Western Blot). HIV-infected individuals may be excluded because immunosuppression could prevent them from responding to the vaccine; chronic hepatitis patients may be excluded due to concerns that vaccination could exacerbate their hepatitis.
- Patients with a history of drug or peptide allergies, or allergies to other potential immunotherapies.
- Patients undergoing chronic steroid treatment (or other immunosuppressive agents, such as azathioprine or cyclosporine A) will be excluded due to potential immunosuppression. Patients must stop any steroid treatment 6 weeks prior to enrollment (except for drugs used for chemotherapy, contrast-enhanced imaging, or acute treatment of complications such as gout attacks <5 days).
- Patients with acute or chronic skin diseases will be excluded, as these conditions could affect the injection into the skin of the limbs or the subsequent evaluation of potential skin reactions.
- Patients without legal capacity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Gen Yang contact
About this study
Evaluation and exploration of the phase I/II clinical safety and efficacy of personalized FAST(Radiation fueled antigens stimulated T-cell immunotherapy )cancer vaccine combined with radiotherapy.
Read the detailed description
Tumor whole-cell vaccines, as one of the methods for tumor immunotherapy, have become a key focus of numerous preclinical studies. Among these, the latest approaches include cryopreserved silica-based vaccines/aged cell vaccines and genetically engineered vaccines. These vaccines induce immunogenic cell death in tumor cells, thereby reshaping the body's immune tolerance and promoting in-situ immunity (in-situ vaccination). They enhance the diversity of tumor-associated antigens in the draining lymph nodes, increase the recruitment of T cells, and promote tumor recognition and anti-tumor effects. At the same time, whole-cell vaccines retain all potential antigens of the tumor cells, and this integrity increases the likelihood of immune activation and recognition of distal tumors. Additionally, since the vaccine uses the patient's own tumor tissue, it reduces the risk of immune overactivation that might be caused by foreign components. Preclinical studies have found that in a surgical resection model of primary tumors in experimental animals, the FAST vaccine can significantly inhibit the recurrence and metastasis of tumor lesions, remodel the immune microenvironment of colonized organs, achieve systemic clearance of micro-metastases, suppress tumor recurrence and metastatic progression, and prolong the survival of the experimental animals. On the other hand, many advanced cancer patients in the clinic are not amenable to surgical resection, with a high tumor burden. Moreover, the immune response induced by the whole-cell autologous FAST vaccine requires a certain period to develop. Therefore, in our preclinical study, the investigators combined FAST vaccine administration with radiotherapy to control local tumors in experimental animals. The results showed that this approach significantly enhanced both innate and adaptive immunity, inhibited tumor progression and metastasis, and improved the survival rate of the experimental animals.
This study aims to recruit tumor patients who have undergone standard surgical treatment and those with advanced tumors who have failed standard treatment or experienced disease progression (after failure of third-line treatment),Using the patient's individualized tumor tissue, the investigators will prepare the FAST tumor cell vaccine and combine it with precision radiotherapy to conduct safety and efficacy studies on tumor patients who meet the inclusion criteria.
- Conditions
- Breast Cancer, Colorectal Cancer, Melanoma, Lung Cancer
- Being tested
- individualized tumor FAST vaccine combination (including adjuvant)
- Keywords
- tumor vaccine, immunogenic cell death, TCV
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Melanoma, Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
individualized tumor FAST vaccine combination (including adjuvant)Biological
Using the patient's individual tumor tissue, an autologous FAST (Fragmented Autoantigen Stimulated T-cell Immunotherapy) vaccine is prepared.
| Study group | Role | What they receive |
|---|---|---|
| standard treatment + adjuvant | No intervention | Patients in the control group include two categories: (1) surgical patients who receive standard postoperative treatment according to guidelines, and (2) non-surgical patients who receive standard RT. |
| Standard treatment + individualized tumor FAST vaccine combination (including adjuvant) | Experimental | Surgical Patients: These patients will receive standard postoperative treatment according to guidelines. In Phase I of the trial, they will be randomly administered the aforementioned low, medium, or high doses of the FAST vaccine (P12). In Phase II, the optimal dose will be selected for each patient (as assessed by an expert panel).
Non-Surgical Patients: Before starting the tumor vaccine, these patients will first undergo three sessions of precision radiotherapy (the doctor will determine whether the patient should receive 2 Gy × 3 or 8 Gy × 3, depending on the patient's condition). After completing the radiotherapy, the individualized tumor vaccine will be administered one week later. Similarly, in Phase I, these patients will receive the low, medium, or high doses of the FAST vaccine (P12) in a randomized manner. In Phase II, the optimal dose will be selected for each patient (as assessed by the expert panel). Tumor vaccine treatment will be administered in cycles of 5 Receives: Biological: individualized tumor FAST vaccine combination (including adjuvant) |
What is being measured
The primary outcome is the main question the study is designed to answer.
safe
The primary endpoint of this study: The Phase I safety evaluation will involve a 3×3 dose escalation of the vaccine (based on a similar international clinical trial, NCT05366062, with low, medium, and high-dose groups, each group receiving 500,000, 1 million, and 2 million cancer cell fragments, respectively, with 3 participants per group). The safety profile will be summarized, including the incidence and severity of adverse events (Evaluation criteria: Treatment toxicity graded according to CTCAE 5, (Common Terminology Criteria for Adverse Events version 5). If the summary of Phase I toxicity shows no significant higher toxicity compared to existing immunotherapies, the study will proceed to the Phase II efficacy trial.
Measured: one month
Secondary outcomes (2)
OS (Overall Survival)
OS (Overall Survival) is defined as the time from the start of FAST treatment to death from any cause.
Measured: 5 years
DFS (disease free survival)
the period of time from the end of treatment or the initial diagnosis of the disease during which the patient shows no signs of disease recurrence, metastasis, or the appearance of new tumors. It is commonly used to assess the disease-free period following cancer treatment.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start25 Mar 2025 (estimated)
- Primary completion1 Mar 2028 (estimated)
- Study completion1 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast Cancer, Colorectal CancerStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 154 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fengming Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital, Peking University
- Responsible party
- Sponsor-investigator, Fengming Kong, The University of Hong Kong-Shenzhen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06756295
- Sponsor's protocol ID
- GCOG0052
- Acronym
- FAST-CR
- Status last verified
- Dec 2024
- First submitted
- 31 Dec 2024
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Li Y, Chen H, Shen Q, Liu Y, Li P, Ma Y, Wang Y, Li S, Yan X, Liu L, Shuai J, Wu M, Ouyang Q, Kong FS, Yang G. Fragment Autoantigens Stimulated T-Cell-Immunotherapy (FAST) as a Fast Autologous Cancer Vaccine. Adv Sci (Weinh). 2025 Jul;12(26):e2502937. doi: 10.1002/advs.202502937. Epub 2025 Mar 26.
PubMed 40135850
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I/ II Study of Fragmented Autoantigen Stimulated T-cell-immunotherapy Combined with Radiotherapy (FAST-CR)
- ClinicalTrials.gov ID
- NCT06756295
- Acronym / sponsor ID
- FAST-CR / GCOG0052
- Conditions
- Breast Cancer, Colorectal Cancer, Melanoma, Lung Cancer
- Keywords
- tumor vaccine, immunogenic cell death, TCV
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 154 participants (estimated)
- Lead sponsor
- Fengming KongUniversity, hospital or other
- Collaborators
- The University of Hong Kong-Shenzhen Hospital, Peking University
- Study start
- 25 Mar 2025 (estimated)
- Primary completion
- 1 Mar 2028 (estimated)
- Study completion
- 1 Mar 2028 (estimated)
- First posted
- 1 Jan 2025 (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.
Evaluation and exploration of the phase I/II clinical safety and efficacy of personalized FAST(Radiation fueled antigens stimulated T-cell immunotherapy )cancer vaccine combined with radiotherapy.
Detailed description
Tumor whole-cell vaccines, as one of the methods for tumor immunotherapy, have become a key focus of numerous preclinical studies. Among these, the latest approaches include cryopreserved silica-based vaccines/aged cell vaccines and genetically engineered vaccines. These vaccines induce immunogenic cell death in tumor cells, thereby reshaping the body's immune tolerance and promoting in-situ immunity (in-situ vaccination). They enhance the diversity of tumor-associated antigens in the draining lymph nodes, increase the recruitment of T cells, and promote tumor recognition and anti-tumor effects. At the same time, whole-cell vaccines retain all potential antigens of the tumor cells, and this integrity increases the likelihood of immune activation and recognition of distal tumors. Additionally, since the vaccine uses the patient's own tumor tissue, it reduces the risk of immune overactivation that might be caused by foreign components. Preclinical studies have found that in a surgical resection model of primary tumors in experimental animals, the FAST vaccine can significantly inhibit the recurrence and metastasis of tumor lesions, remodel the immune microenvironment of colonized organs, achieve systemic clearance of micro-metastases, suppress tumor recurrence and metastatic progression, and prolong the survival of the experimental animals. On the other hand, many advanced cancer patients in the clinic are not amenable to surgical resection, with a high tumor burden. Moreover, the immune response induced by the whole-cell autologous FAST vaccine requires a certain period to develop. Therefore, in our preclinical study, the investigators combined FAST vaccine administration with radiotherapy to control local tumors in experimental animals. The results showed that this approach significantly enhanced both innate and adaptive immunity, inhibited tumor progression and metastasis, and improved the survival rate of the experimental animals.
This study aims to recruit tumor patients who have undergone standard surgical treatment and those with advanced tumors who have failed standard treatment or experienced disease progression (after failure of third-line treatment),Using the patient's individualized tumor tissue, the investigators will prepare the FAST tumor cell vaccine and combine it with precision radiotherapy to conduct safety and efficacy studies on tumor patients who meet the inclusion criteria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| standard treatment + adjuvant | No intervention | –Patients in the control group include two categories: (1) surgical patients who receive standard postoperative treatment according to guidelines, and (2) non-surgical patients who receive standard RT. |
| Standard treatment + individualized tumor FAST vaccine combination (including adjuvant) | Experimental | Biological: individualized tumor FAST vaccine combination (including adjuvant)Surgical Patients: These patients will receive standard postoperative treatment according to guidelines. In Phase I of the trial, they will be randomly administered the aforementioned low, medium, or high doses of the FAST vaccine (P12). In Phase II, the optimal dose will be selected for each patient (as assessed by an expert panel). Non-Surgical Patients: Before starting the tumor vaccine, these patients will first undergo three sessions of precision radiotherapy (the doctor will determine whether the patient should receive 2 Gy × 3 or 8 Gy × 3, depending on the patient's condition). After completing the radiotherapy, the individualized tumor vaccine will be administered one week later. Similarly, in Phase I, these patients will receive the low, medium, or high doses of the FAST vaccine (P12) in a randomized manner. In Phase II, the optimal dose will be selected for each patient (as assessed by the expert panel). Tumor vaccine treatment will be administered in cycles of 5 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Voluntarily agree to participate in this study. Age: 18-80 years, regardless of gender. Pathological and imaging diagnosis of advanced or recurrent malignant tumors. The patient must have previously received systemic standard treatment that has failed or led to disease progression, with no effective first-line treatment options available for advanced tumors (effective treatment options refer to the latest clinical guidelines published by the "Chinese Society of Clinical Oncology"). Alternatively, the patient may have undergone standard surgical treatment for tumor relapse prevention.
- At least one measurable lesion on imaging (excluding patients who have undergone surgical treatment).
- Expected survival ≥ 6 months. ECOG (Eastern Cooperative Oncology Group) performance status score of 0-1. No infectious diseases: HIV antibody negative. Normal hematological function: White blood cells ≥ 3000 cells/µL, hemoglobin ≥ 9 g/dL, platelets ≥ 75,000 cells/µL, absolute neutrophil count > 1000 cells/mm³.
- Normal renal function: Serum creatinine (Cr) ≤ ULN × 1.5. Normal liver function: Serum ALT/AST levels less than three times the upper limit of normal.
- The patient must be willing to sign an informed consent form and able to comply with the treatment plan.
Key exclusion criteria (18 listed)
- Patients who do not have enough tumor resected or puncture tissue for vaccine production.
- Patients who have failed third-line therapy, and whose tumor location or type is not suitable for radiotherapy (as evaluated by the expert group).
- Patients whose tumor tissue preparation for the vaccine does not meet the efficacy assessment criteria before enrollment (individualized FAST vaccine Elispot test, see Appendix 4 for specific testing protocol).
- Patients with a history of bone marrow or stem cell transplantation. Patients currently participating in other therapeutic clinical trials; Traditional Chinese medicine clinical trials.
- Patients with active bacterial or fungal infections as per NCI-CTC (National Cancer Institute Common Terminology Criteria for Adverse Events) CTCAE 5.0.
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 |
|---|---|---|
| individualized tumor FAST vaccine combination (including adjuvant)Using the patient's individual tumor tissue, an autologous FAST (Fragmented Autoantigen Stimulated T-cell Immunotherapy) vaccine is prepared. | Biological | Standard treatment + individualized tumor FAST vaccine combination (including adjuvant) |
Primary outcome
safe
Time frame: one month
The primary endpoint of this study: The Phase I safety evaluation will involve a 3×3 dose escalation of the vaccine (based on a similar international clinical trial, NCT05366062, with low, medium, and high-dose groups, each group receiving 500,000, 1 million, and 2 million cancer cell fragments, respectively, with 3 participants per group). The safety profile will be summarized, including the incidence and severity of adverse events (Evaluation criteria: Treatment toxicity graded according to CTCAE 5, (Common Terminology Criteria for Adverse Events version 5). If the summary of Phase I toxicity shows no significant higher toxicity compared to existing immunotherapies, the study will proceed to the Phase II efficacy trial.
2 secondary outcomes
OS (Overall Survival)
Time frame: 5 years
DFS (disease free survival)
Time frame: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2025.
- Derived from this study: PubMed 40135850Li Y, Chen H, Shen Q, Liu Y, Li P, Ma Y, Wang Y, Li S, Yan X, Liu L, Shuai J, Wu M, Ouyang Q, Kong FS, Yang G. Fragment Autoantigens Stimulated T-Cell-Immunotherapy (FAST) as a Fast Autologous Cancer Vaccine. Adv Sci (Weinh). 2025 Jul;12(26):e2502937. doi: 10.1002/advs.202502937. Epub 2025 Mar 26.
- Individual participant dataSharing planned: No
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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.
Gen Yang contact
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing individualized tumor FAST vaccine combination (including adjuvant) in people with Breast Cancer, Colorectal Cancer and Melanoma, run by Fengming Kong.
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 6 inclusion and 18 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: opening soon, as of the sponsor's last update on 12 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Feng-Ming (Spring) Kong (+86 18807550703, kong0001@hku.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
safe (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06756295, which also lists 1 linked publication.
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 Mar 2025.