AzTrials
AzTrials

Advanced Solid TumorPhase 1NCT05320874

A Study of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors.

A Phase 1 study testing KM257 Bispecific antibody in people with Advanced Solid Tumor, run by Xuanzhu Biopharmaceutical Co., Ltd. at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a first-in-human, 2-part study to investigate the safety, tolerability, pharmacokinetics and efficacy of KM257 by itself and combined with selected chemotherapy agents in patients with advanced HER2-positive or expressing cancers. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Advanced Solid Tumor
What is being tested?
KM257 Bispecific antibody
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
232 participants
Where
1 siteChina
Study dates
Apr 2022to Nov 2026
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

  • Able to understand, voluntarily participate and willing to sign the ICF.
  • Male or female subject >= 18 years and =<75 years.
  • Histologically or cytologically confirmed advanced solid tumors.
  • HER2 positive or expressing.
  • ECOG score 0 or 1.
  • According to the definition of RECIST1.1, for Part1a, the patient has evaluable but Non-measurable lesion can be accepted. For Part1b, the patient has at least one measurable lesion.
Show all 9Show fewer
  • Life expectancy≥12weeks.
  • Adequate organ function.
  • Subjects (women of child-bearing potential and males with fertile female partner) must be willing to use viable contraception method.

Who cannot join

  • primary CNS tumors (including meningeal tumors), symptomatic or untreated CNS metastases(including meningeal metastases).
  • Subjects who had other malignancies in the 2 years prior to the first administration of the investigational drug were excluded in Phase Ib, except those who had basal cell carcinoma, breast cancer in situ, or cervical cancer in situ and had no recurrence and metastasis after radical therapy.
  • Accepted any other anti-tumor drug therapies within 2 weeks before first dose.
  • Accepted major surgery or radical radiotherapy within 4 weeks before first dose; Accepted palliative radiotherapy within 2 weeks before first dose; Accepted radioactive agents(strontium, samarium, etc.)for therapeutic purposes within 8 weeks before first dose.
  • Participating in other studies involving investigational drug(s) ≤ 4 weeks before the first dose of KM257.
  • Subjects with interstitial lung disease or non-infectious pneumonia and related history.
Show all 20Show fewer
  • Infection with HIV disease.
  • Active hepatitis.
  • Had an active infection requiring systemic treatment within 2 weeks prior to initial administration of the investigational drug.
  • Cavity effusion (pleural effusion, ascites, pericardial effusion, etc.) are not well controlled.
  • Subjects are eligible with clinically controlled and stable neurologic function >= 4 weeks, which is no evidence of CNS disease progression; Subjects with
  • Subjects who have received organ transplants.
  • Unresolved toxicities ( Common Terminology Criteria for Adverse Event (CTCAE, version 5), grade greater than or equal to2) from prior anti-cancer therapy. (with the exception of alopecia, the special provisions of inclusion criteria);
  • Subjects who have a history of severe allergic reactions to antibody medications or have a history of severe allergic asthma (CTCAE V5.0 grade ≥3).
  • Subjects with a known history of alcohol or drug abuse.
  • History of myocardial infarction or unstable angina within 6 months prior to enrollment, congestive heart failure (NYHA Class≥2), or clinically significant cardiac disease，LVEF<50%，QTc Fridericia (QTcF) > 470 ms for female, QTc Fridericia (QTcF) > 450 ms for male.
  • History of TIA or stroke within 6 months prior to initial administration of KM257.
  • Subjects known to have a mental illness that may affect trial compliance.
  • The investigator considers that the subject has any clinical or laboratory abnormalities or other reasons that would disqualify him or her from participating in this clinical study.
  • Part1b cohort 2: subjects with known mutations in exons 2, 3, and 4 of KRAS/NRAS and in V600E of BRAF.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Xingming Fan contact

0086-18513114991

fanxingming@xuanzhubio.com

China1 site

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

    Lin Shen, Professor, 0086-10-88196561, doctorshenlin@sina.cn

Other trials in China

About this study

Official title: The Safety, Tolerability, Pharmacokinetic Characteristics and Efficacy of KM257 in Patients With Advanced HER2-positive or Expressing Solid Tumors in a Single-arm, Open-label, Multi-center Phase 1 Clinical Study.

This is a first-in-human, 2-part study to investigate the safety, tolerability, pharmacokinetics and efficacy of KM257 by itself and combined with selected chemotherapy agents in patients with advanced HER2-positive or expressing cancers.

Being tested
KM257 Bispecific antibody
Keywords
KM257, Safety, tolerability, pharmacokinetics and efficacy, Advanced HER2 positive or expressing solid tumors

What participants receive

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

  • KM257 Bispecific antibodyBiological

    Part 1a dose escalation:

    There will be 3 increasing dose levels (3mg/kg,6mg/kg,12mg/kg). Patients will be intravenously administrated with one dose of KM257, QW for continuous cycles of 21 consecutive days for each cycle. The dosing interval may be adjusted during the study based on emerging data from this trial.

    Part 1b dose expansion:

    Part1b:For cohort 1 and cohort2, KM257 will be given at the RP2D identified in Part1a;

    For cohort 3 to 7:KM257 will be given combined with one of the following selected drug combination:

    Drug: Capecitabine Combination therapy with KM257 - Cohort 3

    Drug: Paclitaxel or Docetaxel or Irinotecan Combination therapy with KM257 - Cohort 4

    Drug: Gemcitabine+Cisplatin Combination therapy with KM257 - Cohort 5

    Drug: Gemcitabine+Cisplatin or Carboplatin Combination therapy with KM257 - Cohort 6

    Drug:Carboplatin+Paclitaxel Combination therapy with KM257 - Cohort 7

Study groups in NCT05320874
Study groupRoleWhat they receive
KM257ExperimentalKM257 Bispecific antibody
Receives: Biological: KM257 Bispecific antibody

What is being measured

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

  1. Maximum tolerated dose (MTD) (Part 1a)

    Determine maximum tolerated dose (MTD) of KM257.

    Measured: Up to 3 weeks

  2. Recommended phase 2 dose (RP2D) (if has) (Part 1a)

    Determine recommended phase 2 dose (RP2D) of KM257.

    Measured: Up to 3 weeks

  3. Number of patients with adverse events.(Part 1a)

    Number of patients who experienced an adverse event

    Measured: Up to 8 months.

  4. Objective response rate (ORR) (Part 1b)

    Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment evaluated by investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 2-3 years.

Secondary outcomes (10)

  1. Area under the concentration versus time curve of KM257 in plasma (AUC) (Part 1a and Part1b).

    To determine the AUC of KM257.

    Measured: Up to 8 months for Part 1a; Up to 2 to 3 years for Part1b.

  2. Maximum serum concentration (Cmax) of KM257(Part 1a and Part 1b ).

    To determine the maximum serum concentration (Cmax) of KM257.

    Measured: Up to 63days for Part 1a; Up to 63 days for Part1b.

  3. Time of Maximum observed serum concentration (Tmax) of KM257 (Part1 and Part1b ) .

    To determine the Tmax of KM257.

    Measured: Up to 63days for Part 1a; Up to 63days for Part1b.

  4. Serum Half-life (T-HALF) of KM257. (Part1a and Part1b)

    To determine the t1/2 of KM257.

    Measured: Up to 63days.

  5. Frequency and titer of anti-KM257 antibody. (Part1a and Part1b)

    To determine the immunogenicity of KM257.

    Measured: up to 8months for Part1a and up to 2-3 years for Part1b.

  6. Objective response rate (ORR) (Part 1a)

    Number of participants who achieved a best response of either complete response (CR) or partial response (PR) during treatment evaluated by investigators according to the Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1

    Measured: Up to 8months.

  7. Progression free survival (PFS) (Part 1a and Part 1b)

    To determine the PFS by investigator.

    Measured: up to 2-3 years.

  8. Disease control rate (DCR) (Part 1a and Part 1b)

    To determine the DCR by investigator.

    Measured: up to 2-3 years.

  9. Overall survival (OS) (Part1a and Part1b )

    To determine the OS by investigator.

    Measured: up to 2-3 years.

  10. Number of patients with adverse events (Phase 1b)

    Incidence of AE as assessed by CTCAE 5.0

    Measured: up to 2-3 years.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Apr 2022
  2. Study startApr 2022 (estimated)
  3. Primary completionJun 2024 (estimated)
  4. Study completionNov 2026 (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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
232 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05320874
Sponsor's protocol ID
KM257-1001
Status last verified
Apr 2022
First submitted
1 Apr 2022
Last updated
11 Apr 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing KM257 Bispecific antibody in people with Advanced Solid Tumor, run by Xuanzhu Biopharmaceutical Co., Ltd. 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 20 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 11 Apr 2022. 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?

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 Xingming Fan (0086-18513114991, fanxingming@xuanzhubio.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum tolerated dose (MTD) (Part 1a) (time frame: Up to 3 weeks). 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 NCT05320874.

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 11 Apr 2022.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in