Advanced or Metastatic Solid TumorsPhase 1NCT07260305
A Phase I Study to Investigate the Safety and Tolerability of KGX101 Monotherapy and Combination Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients
A Phase 1 study testing KGX101 injection and Envafolimab in people with Advanced or Metastatic Solid Tumors, run by Kangabio AUSTRALIA LTD PTY at 3 sites in China.
Trial summary
This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Advanced or Metastatic Solid Tumors
- What is being tested?
- KGX101 injection and Envafolimab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 3 sitesChina
- Study dates
- 27 Nov 2024to 30 Mar 2027
- Phase
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit;
- Eastern cooperative oncology grous performance status of 0-1;
- Has at least 1 measurable lesion per RECIST 1.1;
- Has adequate organ and bone marrow function as per study which including hemoglobin > 90 g/L, platelet count >=100*10e9/L, absolute meutrophil count >=1.5*10e9/L;
- Life expectancy of at least 3 months;
- Provision of signed and dated written inform consent prior to any study-related procedures, sampling and analyses.
Who cannot join
- Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, breast cancer;
- Patients with primary CNS malignancies;
- Evidence of severe or uncontrolled systemic diseases, including: active infection, hypertension, chronically unhealed wound or ulcers;
- Active autoimmnue disease requiring systemic treatment in the last 2 years, or immunodefiency which is on immunosuppressive therapy, chronic systemic or enteric steroid therapy;
- History of pneumonitis, interstitial lung disease which require steroids or has current pneumonitis/ interstitial lung disease;
- Any unresolved toxicities from prior therapy greater than CTCAE 5.0 grade 1.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China3 sites, 3 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Director Jiang, +86-010-88197746, gcp_jiangm@bjcancer.org
guoj307@126.com
- Recruiting
Fudan university Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200032
Che Li, +86-021-38196379, Junqian@fudan.edu.cn
Hongxia Wang, MD
- Recruiting
Shanghai Chest Hospital
Shanghai, Shanghai Municipality, 200433
Yu Feng, MD, +86-021-22200000 ext. 7085, xkyyGCP2021@163.com
Shun Lu, MD
About this study
Official title: A Phase I , Open Label, Multi-center Study to Assess the Safety and Tolerability of KGX101 Mono and Combo Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients
This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.
- Conditions
- Advanced or Metastatic Solid Tumors
- Being tested
- KGX101 injection, Envafolimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KGX101 injectionDrug
KGX101 is a heterodimeric IL-12 prodrug with the C-terminus of IL-12 fused with ADCC-impaired IgG1 Fc and the N-terminus of IL-12 masked using the IL-12 binding domains of IL-12Rβ1 and IL-12Rβ2. KGX101 injection is a sterile, white or white-like lyophilized powder, supplied at 4.0 mg/vial for single use.
EnvafolimabDrug
Envafolimab is a novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment formulated for subcutaneous injection.
| Study group | Role | What they receive |
|---|---|---|
| KGX101 monotherapy-Dose level 1 | Experimental | Not described Receives: Drug: KGX101 injection |
| KGX101 monotherapy-Dose level 2 | Experimental | Not described Receives: Drug: KGX101 injection |
| KGX101 monotherapy-Dose level 3 | Experimental | Not described Receives: Drug: KGX101 injection |
| KGX101 monotherapy-Dose level 4 | Experimental | Not described Receives: Drug: KGX101 injection |
| KGX101 monotherapy dose expansion | Experimental | Not described Receives: Drug: KGX101 injection |
| KGX101 combo with Envafolimab-Dose level 1 | Experimental | Not described Receives: Drug: KGX101 injection; Drug: Envafolimab |
| KGX101 combo with Envafolimab-Dose level 2 | Experimental | Not described Receives: Drug: KGX101 injection; Drug: Envafolimab |
| KGX101 combo with Envafolimab-Dose level 3 | Experimental | Not described Receives: Drug: KGX101 injection; Drug: Envafolimab |
| KGX101 combo with Envafolimab dose expansion | Experimental | Not described Receives: Drug: KGX101 injection; Drug: Envafolimab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of participants with adverse events
AE will be collected to assess participants' safety after KGX101 monotherapy or combo with Envafolimab
Measured: From baseline to 30 days after the last dose administration.
Number of participants with dose limiting toxicities/DLT within DLT observation period
DLT will be observed from start of the first priming dose of KGX101 until 21 days post the first target dose of KGX101
Measured: From Day1 after the first priming dose of KGX101 until 21 days post the first target dose ofKGX101
Number of participants with changes of clinical lab abnormalities
Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated
Measured: From screening until 90 days post the last dose administration
The maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab
Measured: From Day 1 post the first dosing until 21 days post the the first target dosing
Secondary outcomes (11)
PK parameters: Maximum Concentration (Cmax) of total IL-12
Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters: Time of maximum observed concentration (Tmax)of total IL-12
Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters: Area under the curve (AUC)
Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters: Half- life (T1 /2)
Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters- Trough concentration (Ctrough)
Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters- Systemic clearance (CL)
Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters- Volume of distribution (Vd)
Part A- The PK schedule after the first and third target dose injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Other sample collection timepoints include: pre-dose of each priming dose, pre-dose of other target dose; Part B- The PK schedule after Envafoliamb: pre-dose (1st, 2nd, 3rd and 4th treatment) and 72h ±1 h post the 1st Envafolimab treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
Immunogenicity- Anti-drug antibody (ADA)
Samples will be collected to assess the immunogeniccity after each KGX101 treatment.
Measured: Part A: From pre-dose of the first dose of KGX101 treatment until 90 days afrer the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until 90 days after the last dose.
Number of participants with changes in the Overall Response (ORR)
Measured: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post the last treatment.
Progression free survival (PFS) per RECIST 1.1
Measured: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.
Overall survival
Measured: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2025
- Study start27 Nov 2024
- Primary completion1 Jan 2027 (estimated)
- Study completion30 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced or Metastatic Solid TumorsStudies 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 57 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kangabio AUSTRALIA LTD PTY
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jun Guo, Principal investigator, Beijing Cancer Hopspital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07260305
- Sponsor's protocol ID
- KGX101ST102
- Status last verified
- Nov 2025
- First submitted
- 17 Nov 2025
- Last updated
- 24 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I , Open Label, Multi-center Study to Assess the Safety and Tolerability of KGX101 Mono and Combo Therapy With Envafolimab in Advanced or Metastatic Solid Tumor Patients
- ClinicalTrials.gov ID
- NCT07260305
- Acronym / sponsor ID
- KGX101ST102
- Conditions
- Advanced or Metastatic Solid Tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 57 participants (estimated)
- Lead sponsor
- Kangabio AUSTRALIA LTD PTYIndustry (pharma, biotech, devices)
- Study start
- 27 Nov 2024 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 30 Mar 2027 (estimated)
- First posted
- 3 Dec 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.
This is a phase I, open-label, multi-center, dose escalation and expansion study in advanced or metastatic solid tumor patients. The're are two goals set in this study: one is to explore the safety and tolerability of KGX101 when mono and combo with envafolimab in Chinese patients, the other is to determine recommended phase 2 dose of KGX101 mono and combo with envafolimab. Participants will: 1. Take drug KGX101 mono or combo with envafolimab every 3 weeks; 2. Visit the clinic for checkups and tests. Schedule will be about 6-8 times in the first month and then about every 3 weeks afterwards.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 9
| Arm | Type | Receives |
|---|---|---|
| KGX101 monotherapy-Dose level 1 | Experimental | Drug: KGX101 injection |
| KGX101 monotherapy-Dose level 2 | Experimental | Drug: KGX101 injection |
| KGX101 monotherapy-Dose level 3 | Experimental | Drug: KGX101 injection |
| KGX101 monotherapy-Dose level 4 | Experimental | Drug: KGX101 injection |
| KGX101 monotherapy dose expansion | Experimental | Drug: KGX101 injection |
| KGX101 combo with Envafolimab-Dose level 1 | Experimental | Drug: KGX101 injection, Drug: Envafolimab |
| KGX101 combo with Envafolimab-Dose level 2 | Experimental | Drug: KGX101 injection, Drug: Envafolimab |
| KGX101 combo with Envafolimab-Dose level 3 | Experimental | Drug: KGX101 injection, Drug: Envafolimab |
| KGX101 combo with Envafolimab dose expansion | Experimental | Drug: KGX101 injection, Drug: Envafolimab |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard of care, no further standard can be used, or standard of care is not fit;
- Eastern cooperative oncology grous performance status of 0-1;
- Has at least 1 measurable lesion per RECIST 1.1;
- Has adequate organ and bone marrow function as per study which including hemoglobin > 90 g/L, platelet count >=100*10e9/L, absolute meutrophil count >=1.5*10e9/L;
- Life expectancy of at least 3 months;
Key exclusion criteria (6 listed)
- Active known second malignancy except adequately treated basal cell carcinoma, squamous cell skin cancer, in situ cervical cancer, breast cancer;
- Patients with primary CNS malignancies;
- Evidence of severe or uncontrolled systemic diseases, including: active infection, hypertension, chronically unhealed wound or ulcers;
- Active autoimmnue disease requiring systemic treatment in the last 2 years, or immunodefiency which is on immunosuppressive therapy, chronic systemic or enteric steroid therapy;
- History of pneumonitis, interstitial lung disease which require steroids or has current pneumonitis/ interstitial lung disease;
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 |
|---|---|---|
| KGX101 injectionKGX101 is a heterodimeric IL-12 prodrug with the C-terminus of IL-12 fused with ADCC-impaired IgG1 Fc and the N-terminus of IL-12 masked using the IL-12 binding domains of IL-12Rβ1 and IL-12Rβ2. KGX101 injection is a sterile, white or white-like lyophilized powder, supplied at 4.0 mg/vial for single use. | Drug | KGX101 combo with Envafolimab dose expansion, KGX101 combo with Envafolimab-Dose level 1, KGX101 combo with Envafolimab-Dose level 2, KGX101 combo with Envafolimab-Dose level 3, KGX101 monotherapy dose expansion, KGX101 monotherapy-Dose level 1, KGX101 monotherapy-Dose level 2, KGX101 monotherapy-Dose level 3, KGX101 monotherapy-Dose level 4 |
| EnvafolimabEnvafolimab is a novel fusion protein of humanized anti-PD-L1 single domain antibody and human IgG1 Fc fragment formulated for subcutaneous injection. | Drug | KGX101 combo with Envafolimab dose expansion, KGX101 combo with Envafolimab-Dose level 1, KGX101 combo with Envafolimab-Dose level 2, KGX101 combo with Envafolimab-Dose level 3 |
Primary outcome
Numbers of participants with adverse events
Time frame: From baseline to 30 days after the last dose administration.
AE will be collected to assess participants' safety after KGX101 monotherapy or combo with Envafolimab
Number of participants with dose limiting toxicities/DLT within DLT observation period
Time frame: From Day1 after the first priming dose of KGX101 until 21 days post the first target dose ofKGX101
DLT will be observed from start of the first priming dose of KGX101 until 21 days post the first target dose of KGX101
Number of participants with changes of clinical lab abnormalities
Time frame: From screening until 90 days post the last dose administration
Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated
The maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab
Time frame: From Day 1 post the first dosing until 21 days post the the first target dosing
11 secondary outcomes
PK parameters: Maximum Concentration (Cmax) of total IL-12
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters: Time of maximum observed concentration (Tmax)of total IL-12
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters: Area under the curve (AUC)
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters: Half- life (T1 /2)
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters- Trough concentration (Ctrough)
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters- Systemic clearance (CL)
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
PK Parameters- Volume of distribution (Vd)
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until Day 1 of the last dose.
Immunogenicity- Anti-drug antibody (ADA)
Time frame: Part A: From pre-dose of the first dose of KGX101 treatment until 90 days afrer the last dose. Part B: From pre-dose of the first dose of KGX101 treatment until 90 days after the last dose.
Number of participants with changes in the Overall Response (ORR)
Time frame: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post the last treatment.
Progression free survival (PFS) per RECIST 1.1
Time frame: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.
Overall survival
Time frame: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.
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 24 Apr 2026.
- 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.
Jun Guo principal investigator
Beijing Cancer Hopspital
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing KGX101 injection and Envafolimab in people with Advanced or Metastatic Solid Tumors, run by Kangabio AUSTRALIA LTD PTY at 3 sites 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 6 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
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 Jun Guo (13911233048, guoj307@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numbers of participants with adverse events (time frame: From baseline to 30 days after the last dose administration.). The study lists 4 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 24 Apr 2026.