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Advanced or Metastatic Solid TumorsPhase 1NCT06074497

This is an Open Label, Two-part, Multicenter, Phase I Trial to Investigate the Safety, Tolerability, and PK of KGX101 Monotherapy and Combination Therapy With Envafolimab in Patients With Advanced or Metastatic Solid Tumors.

A Phase 1 study testing KGX101- Cohort -1, KGX101- Cohort 1 and KGX101- Cohort 2 in people with Advanced or Metastatic Solid Tumors, run by Kangabio AUSTRALIA LTD PTY at 3 sites in Australia.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

This is an open label, two-part, multicenter, multi-regional phase I trial to investigate the safety, tolerability, and PK of KGX101 monotherapy and combination therapy with Envafolimab in patients with advanced or metastatic solid tumors. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Advanced or Metastatic Solid Tumors
What is being tested?
KGX101- Cohort -1, KGX101- Cohort 1 and KGX101- Cohort 2
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
54 participants
Where
3 sitesAustralia
Study dates
13 Dec 2023to 30 May 2028
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Part A: Any histologically or cytologically confirmed solid tumor malignancy that is locally advanced or metastatic and has failed standard therapy, or for which no further standard therapy exists.
  • Part B- In addition to above for Part B, participants should be tumor PD-L1 expression negative or with PD-L1 expression too low to fit for the immune checkpoint inhibitor treatment or have had disease progression after immune checkpoint inhibitor treatment.
  • Age at least 18 years.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 - 1.
  • Has at least 1 measurable lesion per RECIST 1.1 (lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions).
  • Has adequate organ and bone marrow function as per the study (blood transfusion or use of use hematopoietic stimulating factor for correction within 14 days are not permitted):
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  • Hematologic: White blood cell (WBC) count ≥ 3 x 109/L; an absolute neutrophil count ≥ 1.5 x 109/L; a hemoglobin level > 90 g/L; and a platelet count ≥ 100 x 109/L;
  • Adequate hepatic function as defined by:
  • Total bilirubin ≤ 1.5 times the ULN if no liver metastases or ≤ 2.5 times the ULN in the presence of documented Gilbert's Syndrome (unconjugated hyperbilirubinemia) or liver metastases;
  • Aspartate transaminase (AST), alanine transaminase (ALT) and Alkaline phosphatase (ALP) levels ≤ 2.5 x the ULN or ≤ 5 x the ULN for patients with liver metastases;
  • Coagulation international normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 x the ULN;
  • Adequate renal function as defined by a serum creatinine ≤ 1.5 times the ULN concurrent with creatinine clearance ≥ 50 mL/min (calculated by the Cockcroft-- Gault equation);
  • Biochemistry: albumin ≥ 3.0g/dL
  • Willingness of men and women of reproductive potential to observe highly effective birth control for the duration of treatment and for 5 months following the last dose of study drug.
  • Paired pre-treatment archival tumor tissue within two years or fresh tumor biopsy and on-treatment fresh tumor biopsy will be optional. For participants of cutaneous malignant melanoma, paired pre-treatment archival tumor tissue and on-treatment fresh tumor biopsy should be mandatory
  • Life expectancy of approximately 3 months or longer in the opinion of the Investigator.
  • Provision of signed and dated written informed consent prior to any study-specific procedures, sampling, and analyses.

Who cannot join

  • Active known second malignancy with the exception of any of the following: adequately treated basal cell carcinoma, squamous cell skin cancer, or in situ cervical cancer, breast cancer, papillary thyroid carcinoma; adequately treated stage I cancer from which the patient is currently in remission and has been in remission for ≥ 2 years; low risk prostate cancer with Gleason score < 7 and prostate-specific antigen <10ng/mL; any other cancer from which the patient has been disease-free survival for ≥ 5 years.
  • Patients with primary CNS malignancies.
  • A history of allogeneic tissue/solid organ transplant.
  • Any evidence of severe or uncontrolled systemic diseases, including:
  • Active, uncontrolled systemic bacterial, viral, or fungal infection;
  • uncontrolled hypertension (Systolic blood pressure more than equal to 160mHG or diastolic blod pressure more than equal to 100mm HG or poor compliance with anti-hypertensive agents;
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  • or active bleeding diatheses;
  • Clinically significant arrhythmia, unstable angina pectoris, congestive heart failure (class III or IV of New York Heart Association [NYHA]) or acute myocardial infarction within 6 months;
  • Uncontrolled diabetes or poor compliance with hypoglycemic agents;
  • The presence of chronically unhealed wound or ulcers;
  • Other chronic diseases, which, in the opinion of the Investigator, could compromise safety of the patient or the integrity of study.
  • Active autoimmune disease requiring systemic treatment in the past 2 years.
  • Diagnosis of immunodeficiency, is on immunosuppressive therapy, or is receiving chronic systemic or enteric steroid therapy.
  • A history of (non-infectious) pneumonitis / interstitial lung disease that required steroids or has current pneumonitis / interstitial lung disease.
  • HIV-infected participants with a history of Kaposi sarcoma and/or Multicentric Castleman Disease.
  • Active infection as determined by hepatitis B surface antigen and hepatitis B core antigen antibody, or hepatitis B virus DNA by quantitative polymerase chain reaction (qPCR) testing.
  • Active infection as determined by hepatitis C virus (HCV) antibody or HCV RNA by qPCR testing.
  • Major surgery (excluding placement of vascular access) within 4 weeks prior to the first dose of study drug.
  • Treatment with any of the following:
  • Prior treatment with IL-12 therapy (any form, e.g. recombinant human, prodrug, intratumoral, etc.);
  • Presence of CNS metastases that are symptomatic and/or require local CNS directed therapy (such as XRT or surgery) or increasing doses of corticosteroids within 2 weeks prior to the first dose of study drug. Except patients with treated brain metastases should be neurologically stable and receiving less than equal to 10mg per day of prednisone or equivalent prior to study entry;
  • Investigational agent or anticancer therapy (including chemotherapy, biologic therapy, immunotherapy, anticancer Chinese medicine, or anticancer herbal remedy) within 5 half-lives or 4 weeks (whichever is shorter) prior to the first dose of study drug;
  • Radiotherapy within 2 weeks of the start of study treatment. A 1-week washout is permitted for palliative radiation (less than equal to two weeks of radiotherapy) to non-CNS disease;
  • Received a live or live-attenuated vaccine within 30 days of the first dose of study drug; Note: Administration of killed vaccines or other formats are allowed;
  • Diagnosis of immunodeficiency, on immunosuppressive therapy, or receiving chronic systemic or enteric steroid therapy (dose > 10 mg/day of prednisone or equivalent);
  • Prior receipt of an allogeneic stem cell transplant or allogeneic CAR-T cell therapy;
  • Any unresolved toxicities from prior therapy greater than NCI CTCAE version 5.0 Grade 1 at the time of starting study drug with the exception of alopecia and Grade 2 prior platinum-therapy related neuropathy, and medical history conditions requiring maintenance therapy such as, but not limited to, hypothyroidism and adrenal insufficiency, where the principal investigator (PI) has the discretion to determine the appropriate severity classification at study screening, contingent upon the patient's screening labs not showing clinically significant abnormalities and meeting the eligibility requirements as per sponsor and site PI approval.
  • Electrocardiogram QT interval corrected for heart rate (QTc) > 470 msec, measured by Fridericia's formula [QTcF=QT/(RR0.33)]; or any of the following cardiac events within 6 months before screening: Myocardial infarction; unstable angina; unstable symptomatic ischemic heart disease; New York Heart Association class III or IV heart failure; Thromboembolic events (eg, pericardial effusion, restrictive cardiomyopathy, severe untreated valvular stenosis, or severe congenital heart disease).
  • Any illness, medical condition, organ system dysfunction, or social situation (including mental illness or substance abuse), that may interfere with a patient's ability to sign the ICF, adversely affect the patient's ability to cooperate and participate in the study, or compromise interpretation of study results.
  • Pregnant (confirmed by serum beta human chorionic gonadotropin [ HCG]) or lactating.
  • History of hypersensitivity to any of the study drug components; or history experienced grade ≥ 3 irAEs and leads to permanent discontinuation in prior immunotherapy.
  • Part B: participants who are not tolerant to immune checkpoint inhibitor therapy.
  • Participant is known or suspected of not being able to comply with the study protocol (e.g. because of alcoholism, drug dependency, or psychological disorder) or the participant has any condition for which, in the opinion of the Investigator, participation in the study would not be in the best interest of the participant (e.g. compromise their well-being) or that could prevent, limit, or confound the protocol-specified assessments. Or any other disease or clinically medical status that the investigator considers the patient is unstable or may affect their safety or study compliance.

Trial locations and contacts

3 sites in 1 country.

Australia3 sites

  • Pindara Private Hospital

    Benowa, Queensland, 4217

  • Sunshine Coast University Private Hospital

    Birtinya, Queensland, 4575

  • Peninsula & South Eastern Haematology and Oncology Group

    Frankston, Victoria, 3199

Other trials in Australia

About this study

Official title: A Phase 1, First-in-Human, Multicenter, Open-Label, Dose Escalation Trial of KGX101 Monotherapy and in Combination With Envafolimab in Patients With Advanced or Metastatic Solid Tumors.

This is an open label, two-part, multicenter, multi-regional phase I trial to investigate the safety, tolerability, and PK of KGX101 monotherapy and combination therapy with Envafolimab in patients with advanced or metastatic solid tumors.

Read the detailed description

This study will enrol 54 participants depending on the number of dose escalations needed.

The study has 2 parts- Part A monotherapy dose escalation and Part B combination dose escalation. This study will assess KGX101 monotherapy (Part A) and in combination therapy with Envafolimab (Part B) by a standard 3+3 dose escalation design to identify the Maximum Tolerated Dose (MTD) and Recommended Phase 2 Dose (RP2D).

This study schedule will include a 28-day screening, a DLT observation period, followed by variable length study treatment period, 90-day safety follow-up after the last treatment, and survival follow-up every 90 days. Therefore, the total duration of participation will vary for each participant depending on total doses.

A priming dose is the initial lower dose(s) followed by escalation to the full treatment dose(s). Priming dose will be implemented in all cohorts. As the first 3 enrolled previously participants at 0.003 mg/kg didn't receive priming dose, the subsequent enrolled patients at this dose level will receive two priming doses before the target dose. Two priming doses of KGX101 with an dosing interval of 10 days will be recommended. Priming dose regimen may be adjusted by Dose Escalation Committee (DEC) based on the real-time safety, available PK and PD data.

The participants will receive KGX101 intravenous infusion at assigned escalating dose alone or in combined with 400mg Envafolimab every 3 weeks until disease progression or discontinuation criterion is met.

Being tested
KGX101- Cohort -1, KGX101- Cohort 1, KGX101- Cohort 2, KGX101- Cohort 3, KGX101- Cohort 4

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • KGX101- Cohort -1Drug

    Single dose of 0.1, 0.3, 1μg/kg of KGX101 every 3 weeks

  • KGX101- Cohort 1Drug

    Single dose of 0.3, 1.0, 3.0μg/kg of KGX101 every 3 weeks

  • KGX101- Cohort 2Drug

    Single dose of 1, 1 and 3μg/kg of KGX101 every 3 weeks

  • KGX101- Cohort 3Drug

    Single dose of 1,3 and 6μg/kg of KGX101 every 3 weeks

  • KGX101- Cohort 4Drug

    Single dose of 1,3,12μg/kg of KGX101 every 3 weeks

  • KGX101- Cohort 5Drug

    Single dose of 2, 5 and 15 μg/kg of KGX101 every 3 weeks

  • KGX101 and EnvafolimabDrug

    Part B combination therapy KGX101 with Envafolibmab. 400mg to be injected subcutaneously with each target dose of KGX101 every 3 weeks. The dose escalation committee (DEC) may decide to increase the dosage to 600mg. based on PK, PD and safety data.

Study groups in NCT06074497
Study groupRoleWhat they receive
KGX101- Cohort -1ExperimentalDosage level: Dose level 1 Dose form: White-like lyophilized powder Route of administration: Intravenous
Receives: Drug: KGX101- Cohort -1
KGX101- Cohort 1ExperimentalDosage level: Dose level 2. Dose form: White-like lyophilized powder Route of administration: Intravenous
Receives: Drug: KGX101- Cohort 1
KGX101- Cohort 2ExperimentalDosage level: Dose level 3 Dose form: White-like lyophilized powder Route of administration: Intravenous
Receives: Drug: KGX101- Cohort 2
KGX101- Cohort 3ExperimentalDosage level: Dose level 4 Dose form: White-like lyophilized powder Route of administration: Intravenous
Receives: Drug: KGX101- Cohort 3
KGX101- Cohort 4ExperimentalDosage level: Dose level 5 Dose form: White-like lyophilized powder Route of administration: Intravenous
Receives: Drug: KGX101- Cohort 4
KGX101- Cohort 5ExperimentalDosage level: Dose level 6 Dose form: White-like lyophilized powder Route of administration: Intravenous
Receives: Drug: KGX101- Cohort 5
KGX101 and EnvafolimabActive comparatorPart B combination therapy KGX101 with Envafolibmab. Dose form: Injection Route to administration: Injection
Receives: Drug: KGX101 and Envafolimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of participants with Treatment emergent Adverse events (TEAEs)

    TEAE will be collected to assess participants' safety after KGX101 treatment.

    Measured: From baseline to 30 days after the last dose administration.

  2. Number of participants with Dose Limiting Toxicities (DLTs) at week 4

    DLT will be observed from start of treatment until 21 days post the first target dose treatment.

    Measured: From Day 1 after the first dose of KGX101 full treatment to D21 post dose.

  3. Number of participants with changes to clinical laboratory abnormalities

    Any changes in values of the clinical chemistry, hematology, coagulation and urinalysis will be evaluated.

    Measured: Screening to 90 days post last dose administration

  4. To estimate the Maximum tolerated dose of KGX101 monotherapy and combination therapy with Envafolimab.

    Measured: From Day 1 after the first dose of KGX101 full treatment to D21 post dose.

Secondary outcomes (13)

  1. PK Parameters: Maximum Concentration (Cmax)

    Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  2. PK Parameters: Time of maximum observed concentration (Tmax)

    Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  3. PK Parameters: Area under the curve (AUC)

    Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  4. PK Parameters: Half- life (T1 /2)

    Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  5. PK Parameters- Trough concentration (Ctrough)

    Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  6. PK Parameters- Systemic clearance (CL)

    Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  7. Immunogenicity- Anti-drug antibody (ADA)

    Samples will be collected to assess the immunogeniccity after KGX101 treatment.

    Measured: Part A- From pre-dose of the first dose of KGX101 full treatment to Day 90 hours after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  8. PK Parameters- Volume of distribution (Vd)

    Part A- The PK schedule after the 1st and 4th injection of KGX101 are as follows: pre-dose, 0 h, 2, 6, 24, 48, 72, 168 and 336hr post dose. Part B- 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 full treatment to Day 90 hours after the first and 4th dose of full treatment; Part B- Predose and 72hrs (only 1st treatment)

  9. Number of participants with changes in the Investigator-assessed confirmed Best Overall Response (BOR)

    Measured: From Day 1 after the first dose of KGX101 full treatment to D21 post dose.

  10. 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 last treatment.

  11. 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.

  12. Overall survival

    Measured: From Day 1 after the first dose of KGX101 till survival follow-up every 90 days post last treatment.

  13. Change in serum concentration of KGX101 and total IL-12

    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.

  1. First posted10 Oct 2023
  2. Study start13 Dec 2023
  3. Primary completion30 May 2026 (estimated)
  4. Study completion30 May 2028 (estimated)

Resources

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
Sequential
Masking
None (open label)
Enrolment
54 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06074497
Sponsor's protocol ID
KGX101ST101
Status last verified
Jan 2026
First submitted
3 Oct 2023
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KGX101- Cohort -1, KGX101- Cohort 1 and KGX101- Cohort 2 in people with Advanced or Metastatic Solid Tumors, run by Kangabio AUSTRALIA LTD PTY at 3 sites in Australia.

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 17 inclusion and 33 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: under way, not looking for participants, as of the sponsor's last update on 29 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 Australia. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of participants with Treatment emergent Adverse events (TEAEs) (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?

On the ClinicalTrials.gov record for NCT06074497.

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 29 Apr 2026; AzTrials last refreshed its copy on 30 Oct 2026.

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