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.
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.
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.
Single group
KM257 Bispecific antibody
Biological/VaccinePart 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
Maximum tolerated dose (MTD) (Part 1a)
Determine maximum tolerated dose (MTD) of KM257.
Recommended phase 2 dose (RP2D) (if has) (Part 1a)
Determine recommended phase 2 dose (RP2D) of KM257.
Number of patients with adverse events.(Part 1a)
Number of patients who experienced an adverse event
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
Area under the concentration versus time curve of KM257 in plasma (AUC) (Part 1a and Part1b).
To determine the AUC of KM257.
Maximum serum concentration (Cmax) of KM257(Part 1a and Part 1b ).
To determine the maximum serum concentration (Cmax) of KM257.
Time of Maximum observed serum concentration (Tmax) of KM257 (Part1 and Part1b ) .
To determine the Tmax of KM257.
Serum Half-life (T-HALF) of KM257. (Part1a and Part1b)
To determine the t1/2 of KM257.
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